CDER Small Business and Industry Assistance (SBIA) Learn

The table below lists SBIA multimedia training resources, including conference/webinar presentations and recordings, online courses, newsletters and podcasts.  Explore the SBIA recordings on YouTube to browse by most popular videos and see upcoming events for a list of future live events.

You can now find Spanish captions for selected training modules as the FDA expands language accessibility to audiences in the Latin America Region and the U.S. Click “Subtítulos en Español” to the right of the list below to use this feature. You can also find this training on our SBIA Spanish Captions YouTube playlist.

Ahora se tienen subtítulos en español para módulos de capacitación seleccionados ya que la FDA está ampliando la accesibilidad en cuanto al idioma para audiencias en la región de América Latina y los Estados Unidos. Haga clic en “Subtítulos en Español” a la derecha de la siguiente lista para utilizar esta modalidad. También puede encontrar esta capacitación en nuestra lista de reproducción en español en YouTube.

SBIA Recordings on YouTube

Upcoming SBIA Events

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Type CDERLearn CourseConference/WorkshopOn DemandSBIA ChroniclesSBIA Chronicles PodcastSymposiumWebinar

Topic Advanced ManufacturingAnalytical ValidationANDAAnimal RuleArtificial IntelligenceBioanalysisBioavailabilityBioequivalenceBiologicsBiomarkersBiosimilarsBLAChemistry Manufacturing and Controls (CMC)Clinical PharmacologyClinical Trials and ResearchClinicalTrials.govCombination ProductsComplex Generic DrugCompoundingContinuous ManufacturingControlled CorrespondenceCurrent Good Manufacturing Practice (CGMP)Data ManagementData StandardsDelivery SystemDevicesDigital Health TechnologiesDistributorDrug DevelopmentDrug InteractionDrug Master FilesDrug QualityDrug SafetyDrug Supply ChainDSCSAElectronic SubmissionsEmerging TechnologyFDA Form 483FDA Meetings/CommunicationsGeneric Drug DevelopmentGood Laboratory PracticeImport/ExportINDInspectionsIntegrated Safety AnalysesInternationalInvestigationsLabelingLipidLiposomeManufacturingMarketingMeetingsNanomaterialsNDANew Drug DevelopmentNoncirrhotic NASHNon-ClinicalNoninvasive testsOTC Drug RegulationPost ApprovalProduct Specific GuidancesQuality AssessmentsRadiolabeled Mass BalanceReal World EvidenceRecallsRegistration and ListingRegulatory AssessmentRegulatory ScienceRegulatory SubmissionsResourcesRisk ManagementRisk Evaluation and Mitigation Strategy (REMS)SafetyStatistical AnalysisSupply ChainSurrogate EndpointsTherapeutic ProteinUnique Serial NumbersUser FeesWholesaler

 

Summary	Type	Issued/Updated	Topic	Subtítulos en Español
M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance	Webinar	11/21/2024	ANDA, Bioequivalence, Generic Drug Development, International	No
Clinical Pharmacology Considerations for Radiolabeled Mass Balance Studies	Webinar	11/12/2024	Clinical Pharmacology, Clinical Trials and Research, Drug Safety, IND, International, New Drug Development, Radiolabeled Mass Balance	No
Putting the Pieces Together: REMS Logic Model in REMS Design, Implementation, and Evaluation	Webinar	11/7/2024	ANDA, BLA, Drug Safety, New Drug Development, Risk Management, Risk Evaluation and Mitigation Strategy (REMS)	No
Global IDMP Implementation - Getting Closer to the Goal	Webinar	10/16/2024	Data Standards, Drug Shortages, Labeling, Electronic Submissions, Pharmacovigilance, Regulatory Submissions	No
ICH M12 Drug-Drug Interaction Studies Final Guidance	Webinar	10/9/2024	Drug Interaction, New Drug Development, IND	No
Advancing Generic Drug Development: Translating Science to Approval 2024	Conference/Workshop	9/24/2024	ANDA, Complex Generic Drug, Product Specific Guidances, Generic Drug Development, Regulatory Assessment	No
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2024	Conference/Workshop	9/12/2024	Import/Export, International, Registration and Listing	No
ANDA Submissions – Amendments to Abbreviated New Drug Applications under GDUFA	Webinar	9/10/2024	ANDA, Generic Drug Development, Regulatory Submissions	No
FDA | NIH : Regulatory Do’s and Don’ts: Tips from FDA	Webinar	9/4/2024	Biologics, Chemistry, Manufacturing, and Controls (CMC), Clinical Trials and Research, Early Product Development, Devices, Digital Health Technologies, Drug Development	No
Environmental Monitoring in Compounding	Webinar	7/30/2024	Compounding, Environmental Monitoring, Outsourcing Facilities	No
Dataset-JSON Pilot Report and Next Steps	Webinar	7/25/2024	Data Standards, International, Regulatory Science, Regulatory Submissions	No
Introduction to FDA’s Office of Trade and Global Partnerships	Webinar	7/23/2024	Combination Products, Drug Supply, International Trade	No
Office of Pharmaceutical Quality (OPQ) Reorganization	On Demand	7/16/2024	Drug Quality, Emerging Technology, International, Manufacturing, Quality Assessments, Supply Chain	No
Rx Drug Promotion and the Clear, Conspicuous, and Neutral Final Rule	Webinar	6/26/2024	Advertising, Marketing, Regulatory Submissions	No
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2024 User Fees and Registration	Webinar	6/18/2024	OTC Regulation, User Fees	No
OSIS Workshop: CDER Inspections of Good Laboratory Practice and Bioavailability/Bioequivalence Study Sites	Webinar	6/13/2024	Animal Rule, Bioanalysis, Bioavailability, Bioequivalence, Clinical Trials and Research, Good Laboratory Practice	No
Regulatory Education for Industry (REdI) Annual Conference 2024: Innovation in Medical Product Development	Conference/Workshop	5/29/2024	Advanced Manufacturing, Artificial Intelligence, Biologics, Clinical Trials and Research, Combination Products, Devices, Drug Safety, Drug Supply Chain, Electronic Submissions, New Drug Development	No
Considerations for Drug Products that Contain Nanomaterials	SBIA Chronicles Podcast	5/17/2024	Nanomaterials	No
Considerations for Drug Products that Contain Nanomaterials	SBIA Chronicles	5/17/2024	Nanomaterials	No
Statistical Considerations for Premarketing Risk Assessment	Webinar	5/16/2024	Clinical Trials and Research, New Drug Development, Integrated Safety Analyses	No
Redesigned Pre-Submission Meetings in GDUFA III: Benefits for ANDA Submission and Approval	Webinar	5/9/2024	ANDA, Generic Drug Development, Meetings, Regulatory Assessments	No
Facilitating Generic Drug Product Development through Product-Specific Guidances	Webinar	4/25/2024	ANDA, Bioequivalence, Generic Drug Development, Product Specific Guidances	No
Generic Drugs Forum (GDF) 2024: Regulatory Considerations to Enhance Generic Drug Access	Conference/Workshop	4/10/2024	ANDA, Bioequivalence, Chemistry Manufacturing and Controls (CMC), Controlled Correspondence, Generic Drug Development, Meetings, Product Specific Guidances	No
Expanding Generic Drug Access Through International Engagements	Webinar	2/28/2024	ANDA, Bioequivalence, Clinical Trials and Research, Complex Generic Drug, Generic Drug Development, International	No
Integrated Safety Analyses in Drug Marketing Applications: Avoiding Common Mistakes	Webinar	3/7/2024	Clinical Trials and Research, New Drug Development, Integrated Safety Analyses	No
Joint US FDA – Health Canada ICH Public Meeting	Webinar	2/22/2024	International, New Drug Development, Generic Drug Development, Safety, Real Word Evidence, Analytical Validation, Drug Safety, Data Management	No
A Deep Dive: FDA’s Model-Integrated Evidence (MIE) Industry Meeting Pilot Program for Generic Drugs	Webinar	1/18/2024	Generic Drug Development, Bioequivalence, ANDA, Meetings	No
eCTD (7/28) Generic Drugs Forum 201	Webinar	4/4/2017	ANDA, Generic Drug Development, Regulatory Submissions	Disponible/Available
Introduction to “The ANDA Review Pathway” (11/28) Generic Drugs Forum 2017	Webinar	4/4/2017	ANDA, Generic Drug Development, Regulatory Submissions	Disponible/Available
FDA’s Bioequivalence Recommendations for Generic Drugs (16/28) Generic Drugs Forum 2017	Webinar	4/4/2017	ANDA, Bioequivalence, Generic Drug Development, Regulatory Assessment	Disponible/Available
Manufacturing Process and Controls (25/28) Generic Drugs Forum 2017	Webinar	4/4/2017	ANDA, Chemistry Manufacturing and Contgrols (CMC), Drug Quality, Generic Drug Development	Disponible/Available
Drug Master Files (DMFs) from an ANDA Perspective (7of28) Generic Drugs Forum – Apr. 3-4, 2019	Webinar	4/3/2019	ANDA, Drug Master Files, Generic Drug Development, Regulatory Assessment, Regulatory Submissions	Disponible/Available
Orange Book - Its Role in ANDAs (8of28) Generic Drugs Forum – Apr. 3-4, 2019	Webinar	4/3/2019	ANDA;Generic Drug Development; New Drug Development; Orange Book	Disponible/Available
Product Specific Guidances (PSGs) Generic Drugs Forum 2020	Webinar	4/15/2020	ANDA; Complex Generic Drug; Generic Drug Development; Product Specific Guidances	Disponible/Available
Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020	Webinar	6/30/2020	Manufacturing; Regulatory Submissions	Disponible/Available
FDA Drug Manufacturing Inspections - REdI 2020	Webinar	6/30/2020	Manufacturing; Inspections; Regulatory Submissions	Disponible/Available
ANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues	Webinar	4/28/2021	ANDA; Generic Drug Development; Quality Assessments	Disponible/Available
A Joint US-FDA | MHRA-UK | Health Canada Good Clinical Practice & Pharmacovigilance Compliance Symposium	Symposium	2/13/2024	New Drug Development, Clinical Trials and Research, ANDA, Bioequivalence, BLA, Digital Health Technologies, International, Regulatory Assessment, Inspections	No
Navigating Complex Waters: A Deep Dive into FDA Drug Interactions Guidances and Resources	Webinar	12/12/2023	IND, Labeling, Drug Interaction, Therapeutic Protein	No
FDA Clinical Investigator Training Course (CITC) 2023	Conference/Workshop	12/6/2023	IND, Clinical Trials and Research, New Drug Development, Real World Evidence, International, Digital Health Technologies	No
Toward Global IDMP Implementation: A Focus on Global Use Cases	Webinar	11/28/2023	Regulatory Submissions, Data Standards	No
Common Issues with SEND Data Submitted for Safety Pharmacology Studies	Webinar	11/16/2023	Regulatory Submissions, Data Standards	No
Implementing DSCSA: Stabilization Period and Expectations	Webinar	11/3/2023	DCSA, Compliance, Drug Supply Chain, Wholesaler, Distributor, Unique Serial Numbers	No
Pharmaceutical Quality Symposium 2023: Quality, Supply Chain & Advanced Manufacturing	Symposium	10/31/2023	Drug Quality, Quality Assessments, Supply Chain, Manufacturing, Emerging Technology	No
BsUFA III Regulatory Science Pilot Program	Webinar	10/16/2023	Biomarkers, Regulatory Science, BLA, Biologics	No
2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials	Symposium	10/11/2023	Generic Drug Development, New Drug Development, IND, NDA, BLA, ANDA, Nanomaterials, Non-Clinical, Quality Assessment, Continuous Manufacturing, Regulatory Science, Delivery System, Lipid, Liposome	No
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct - 2023	Conference/Workshop	9/28/2023	Registration and Listing, Import/Export	No
Use of Biomarkers for Diagnosing and Assessing Treatment Response in Noncirrhotic NASH Trials	Conference/Workshop	9/18/2023	Clinical Trials and Research, New Drug Development, Biomarkers, Surrogate Endpoints, Noninvasive tests, Noncirrhotic NASH	No
Advancing Generic Drug Development: Translating Science to Approval 2023	Conference/Workshop	9/13/2023	ANDA, Generic Drug Development, Complex Generic Drug, Product Specific Guidances, Regulatory Assessment	No
Understanding FDA Inspections and Data	Webinar	9/6/2023	Inspections, International, Current Good Manufacturing Practice (CGMP)	No
OTC Monograph Reform: OMOR Format and Content & Electronic Submissions	Webinar	8/22/2023	OTC Drug Regulation, Regulatory Submissions, ANDA, NDA, New Drug Development	No
Using Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products	SBIA Chronicles Podcast	8/17/2023	Clinical Trials and Research	No
Using Bayesian Statistical Approaches to Advance our Ability to Evaluate Drug Products	SBIA Chronicles	8/17/2023	Clinical Trials and Research	No
ClinicalTrials.gov – a Three-Part Series	Webinar	8/9/2023	ClinicalTrials.gov, Clinical Trials and Research	No
Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products	SBIA Chronicles	7/11/2023	Generic Drug Development	No
Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products	SBIA Chronicles Podcast	7/11/2023	Generic Drug Development	No
Decentralized Clinical Trials (DCT) Draft Guidance	Webinar	6/20/2023	Clinical Trials and Research, IND, New Drug Development	No
Overview: Clinical Pharmacology Considerations for Food Effect Studies	Webinar	6/15/2023	Drug Development, Regulatory Submissions	No
Regulatory Education for Industry (REdI) Annual Conference 2023	Conference/Workshop	6/5/2023	BLA, Chemistry Manufacturing and Controls (CMC), Digital Health Technologies, Drug Development, FDA Meetings/Communications, IND, NDA, New Drug Development, Real World Evidence, and Regulatory Submissions	No
An Update on Field Alert Reports (FAR) and Biological Product Deviation Reports (BPDR)	Webinar	5/24/2023	Drug Quality, Regulatory Submissions, and Quality Assessments	No
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2023 User Fees and Registration	Webinar	5/16/2023	OTC Drug Regulation, User Fees	No
A Deep Dive: GDUFA III Scientific Meetings	Webinar	5/15/2023	ANDA, Generic Drug Development, FDA Meetings/Communications	No
Navigating the First ICH Generic Drug Draft Guideline “M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms”	Webinar	5/2/2023	Generic Drug Development, International	No
Electronic Systems, Electronic Records, and Electronic Signatures Webinar	Webinar	4/25/2023	New Drug Development, Clinical Trials and Research, IND	No
FDA’s Dosage and Administration Section of Labeling Draft Guidance	Webinar	4/19/2023	Labeling	No
The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development	SBIA Chronicles Podcast	4/10/2023	Biosimilars	No
The Role of Pharmacodynamic Biomarkers in Biosimilar Drug Development	SBIA Chronicles	4/10/2023	Biosimilars	No
Generic Drugs Forum (GDF) 2023: Celebrating 10 Years of the GDF	Conference/Workshop	4/7/2023	Generic Drug Development	No
A Deep Dive: FDA Draft Guidance on Statistical Approaches to Establishing Bioequivalence	Webinar	3/14/2023	Bioequivalence, Generic Drug Development, Drug Development	No
Joint US FDA – Health Canada ICH Public Meeting	Webinar	2/24/2023	Clinical Trials and Research, International, New Drug Development	No
Overview: Clinical Pharmacology Considerations for Neonatal Studies	Webinar	2/15/2023	Clinical Trials and Research, IND, NDA, BLA, New Drug Development	No
FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds	SBIA Chronicles	2/6/2023	Drug Quality	No
FDA Regulation and Quality Considerations for Cannabis and Cannabis-Derived Compounds	SBIA Chronicles Podcast	2/6/2023	Drug Quality	No
Overview of FDA’s Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use	Webinar	2/1/2023	OTC Drug Regulation	No
FDA’s Labeling Resources for Human Prescription Drugs	Webinar	1/26/2023	Labeling	No
Reporting Individual Case Study Reports (ICSRs) to FAERS Using ICH E2B R3 Standards	Webinar	1/13/2023	Regulatory Submissions, Safety	No
What to Expect after an Inspection: 483s, Responses and Beyond	Webinar	12/14/2022	Compliance, Compounding, Inspections, FDA Form 483	No
FDA Clinical Investigator Training Course (CITC) 2022	Conference/Workshop	12/7/2022	IND, Clinical Trials and Research, New Drug Development, Real World Evidence, International, Digital Health Technologies	No
Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions	Conference/Workshop	11/30/2022	ANDA, Drug Master Files, Generic Drug Development, Regulatory Submissions, Quality Assessments	No
Proposed Rule: Revising the National Drug Code Format and Drug Label Barcode Requirements	Webinar	11/17/2022	Registration and Listing	No
An In-Depth Look at the Final FDA Guidance: Bioavailability Studies Submitted in NDAs or INDs – General Considerations	Webinar	10/26/2022	Drug Development, New Drug Development, Bioequivalence, Bioavailability, IND, NDA	No
FDA NanoDay Symposium 2022	Symposium	10/11/2022	Generic Drug Development, New Drug Development, IND, NDA, Chemistry Manufacturing and Controls (CMC), Nanomaterials, Non-Clinical, ANDA	No
Study Data Standards Update for CBER: Your Guide to a Successful Submission	Webinar	10/6/2022	Data Standards, Regulatory Submissions	No
The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities	SBIA Chronicles	9/29/2022	Compounding	No
The FDA Compounding Incidents Program: Adverse Events Associated with Compounded Drugs from Outsourcing Facilities	SBIA Chronicles Podcast	9/29/2022	Compounding	No
Advancing Generic Drug Development: Translating Science to Approval	Conference/Workshop	9/20/2022	Generic Drug Development, Drug Quality, Regulatory Submissions	No
Reporting Drug Amount Under Section 510(j)(3) of the FD&C Act	Webinar	9/8/2022	Registration and Listing	No
Regulatory Best Practices for Global Access to Medicines, Including Anti-TB Medicines	Conference/Workshop	8/16/2022	Drug Development, Drug Quality, Generic Drug Development, New Drug Development, IND, International, Post Approval	No
Best Practices for Topical Generic Product Development and ANDA Submission	Webinar	8/11/2022	Generic Drug Development	No
Decoding the Guidance: Considerations for Waiver Requests for pH Adjusters in Generic Drug Products Intended for Parenteral, Ophthalmic, or Otic Use	Webinar	8/10/2022	Generic Drug Development	No
Office of Study Integrity and Surveillance (OSIS) Workshop 2022: CDER Inspections of Good Laboratory Practice, Animal Rule, and Bioavailability/Bioequivalence Study Sites	Conference/Workshop	7/19/2022	Drug Development, Inspections, New Drug Development, IND	No
An FDA Self-Audit of Continuous Manufacturing for Drug Products	SBIA Chronicles	6/28/2022	Drug Quality	No
An FDA Self-Audit of Continuous Manufacturing for Drug Products	SBIA Chronicles Podcast	6/28/2022	Drug Quality	No
Regulatory Education for Industry (REdI) Annual Conference 2022	Conference/Workshop	6/6/2022	Biosimilars, Drug Development, DSCSA, FDA Meetings/Communications, Inspections, NDA, New Drug Development, Regulatory Submissions, Resources, Safety	No
Quality Management Maturity Workshop	Webinar	5/24/2022	Drug Quality	No
US-Canada Regional ICH Consultation	Webinar	5/11/2022	Clinical Trials and Research; International; New Drug Development	No
FDA Workshop on the Role of Phytosterols in PNALD/IFALD	Webinar	5/6/2022	Drug Development	No
Generic Drugs Forum 2022: The Current State of Generic Drugs	Conference/Workshop	4/26/2022	Generic Drug Development	No
The Key Elements of Being “Recall-Ready”	CDER SBIA Chronicles	4/20/2022	Recalls	No
The Key Elements of Being "Recall-Ready"	CDER SBIA Chronicles Podcast	4/20/2022	Recalls	No
Proposed Rule: National Standards for the Licensure of Wholesale Drug Distributors and Third-Party Logistics Providers	Webinar	4/13/2022	DSCSA	No
FDA Inspections of Outsourcing Facilities	Webinar	4/6/2022	Compounding, Inspections	No
Immunogenicity Information in Labeling	Webinar	4/5/2022	Drug Development, Labeling	No
OTC Monograph Reform: Overview of Draft Guidance for Formal Meetings	Webinar	3/29/2022	OTC Drug Regulation, Clinical Trials and Research, Regulatory Submissions, FDA Meetings/Communications	No
FDA-EMA Parallel Scientific Advice (PSA) Program	Webinar	3/16/2022	New Drug Development, Drug Development, International, Regulatory Submissions	No
Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA	Webinar	2/24/2022	Drug Development, Generic Drug Development	No
CDER BIMO GCP Compliance and Enforcement	Webinar	2/16/2022	Clinical Trials and Research, Inspections, New Drug Development	No
Digital Health Technologies (DHTs) for Remote Data Acquisition Draft Guidance	Webinar	2/10/2022	New Drug Development, Clinical Trials and Research, IND	No
Toward Global Identification of Medicinal Products (IDMP) Implementation: A Focus on Biologics	Webinar	1/27/2022	New Drug Development, Labeling, Post Approval, Clinical Trials and Research	No
OTC Monograph Reform: Deemed Final Orders	Webinar	12/15/2021	OTC Drug Regulation	No
OTC Monograph Reform: OTC Sunscreen Drugs	Webinar	12/15/2021	OTC Drug Regulation	No
Clinical Investigator Training Course (CITC) Update	Webinar	12/7/2021	Clinical Trials and Research, New Drug Development	No
Pharmaceutical Quality Symposium 2021: Innovations in a Changing World	Conference/Workshop	10/26/2021	Drug Quality	No
Pharmaceutical Quality Symposium 2021 Part 1 with Keynote Addresses	Conference/Workshop	10/26/2021	Drug Quality	No
Pharmaceutical Quality Symposium 2021 Part 2, FDA Leaders Panel Discussion	Conference/Workshop	10/26/2021	Drug Quality	No
Pharmaceutical Quality Symposium 2021 Part 3 Panel Questions and Discussion	Conference/Workshop	10/26/2021	Drug Quality	No
Pharmaceutical Quality Symposium 2021 Part 4	Conference/Workshop	10/26/2021	Drug Quality	No
Pharmaceutical Quality Symposium 2021 Part 5	Conference/Workshop	10/26/2021	Drug Quality	No
Pharmaceutical Quality Symposium 2021 Part 6	Conference/Workshop	10/26/2021	Drug Quality	No
Pharmaceutical Quality Symposium 2021 Part 7	Conference/Workshop	10/26/2021	Drug Quality	No
Pharmaceutical Quality Symposium 2021 Part 8	Conference/Workshop	10/26/2021	Drug Quality	No
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 1 with Keynote Address	Conference/Workshop	10/13/2021	Registration and Listing	No
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 2	Conference/Workshop	10/13/2021	Registration and Listing	No
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 3	Conference/Workshop	10/13/2021	Registration and Listing	No
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Part 4 with Closing Remarks	Conference/Workshop	10/13/2021	Registration and Listing	No
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct	Conference/Workshop	10/13/2021	Registration and Listing	No
Enhanced Drug Distribution Security in 2023 Under the DSCSA	Webinar	10/5/2021	DSCSA	No
Investigator Responsibilities — Safety Reporting for Investigational Drugs and Device	Webinar	9/29/2021	IND, Safety	No
Advancing Generic Drug Development: Translating Science to Approval	Conference/Workshop	9/21/2021	Generic Drug Development	No
Advancing Generic Drug Development: Translating Science to Approval Keynote Address	Conference/Workshop	9/15/2021	Generic Drug Development	No
COVID-19 Impact on Generic Drug Regulation and Evaluation + QA	Conference/Workshop	9/15/2021	Generic Drug Development	No
Considerations in Assessing Generic Drug Products of Oral Dosage Forms + QA	Conference/Workshop	9/15/2021	Generic Drug Development	No
Complex Generics_Complex Injectables, Opthalmic, and Otic Products, Part 1 + QA	Conference/Workshop	9/15/2021	Generic Drug Development	No
Complex Generics_Complex Injectables, Opthalmic, and Otic Products, Part 2 + QA	Conference/Workshop	9/15/2021	Generic Drug Development	No
Advancing Generic Drug Development: Translating Science to Approval, Day One Closing Remarks	Conference/Workshop	9/15/2021	Generic Drug Development	No
Cutting Edge Science in Complex Generics + QA	Conference/Workshop	9/15/2021	Generic Drug Development	No
Complex Generics_Nasal and Inhalation Products + QA	Conference/Workshop	9/15/2021	Generic Drug Development	No
Complex Generics_Topical Products, Part 1 + QA	Conference/Workshop	9/15/2021	Generic Drug Development	No
Complex Generics_Topical Products, Part 2 + QA	Conference/Workshop	9/15/2021	Generic Drug Development	No
Advancing Generic Drug Development: Translating Science to Approval, Day Two Closing Remarks	Conference/Workshop	9/15/2021	Generic Drug Development	No
The ABCs of Product Specific Guidances	CDER SBIA Chronicles	9/2/2021	Generic Drug Development	No
The ABCs of Product Specific Guidances	CDER SBIA Chronicles Podcast	9/2/2021	Generic Drug Development	No
Promotional Submissions in eCTD Format – Grouped Submissions	Webinar	8/31/2021	Regulatory Submissions	No
Manufacturing, Supply Chain, and Inspections during the COVID19 Public Health Emergency	Webinar	8/25/2021	Inspections; Drug Quality; DSCSA	No
Regulatory Education for Industry (REdI) Annual Conference 2021	Conference/Workshop	7/19/2021	New Drug Development	No
2021 REdI Conference Keynote Address by Janet Woodcock, MD	Conference/Workshop	7/19/2021	New Drug Development	No
2021 REdI Conference Plenary Session with Patrizia Cavazzoni, MD	Conference/Workshop	7/19/2021	New Drug Development	No
OND Reorganization and the New Drugs Regulatory Program Modernization	Conference/Workshop	7/19/2021	New Drug Development	No
ANDA Efforts Related to COVID-19	Conference/Workshop	7/19/2021	Generic Drug Development	No
Resource Capacity Planning: How CDER is Modernizing Resource Planning Capabilities	Conference/Workshop	7/19/2021	New Drug Development	No
CDER NextGen Portal	Conference/Workshop	7/19/2021	Regulatory Submissions	No
Electronic Common Technical Document (eCTD)	Conference/Workshop	7/19/2021	Regulatory Submissions	No
Product Quality Consideration for Emergency Use Authorizations (EUAs)	Conference/Workshop	7/19/2021	New Drug Development	No
Strategies to Address Potential Medication Errors for EUA Products for COVID-19	Conference/Workshop	7/19/2021	New Drug Development; Safety	No
Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine	Conference/Workshop	7/19/2021	New Drug Development	No
CDER’s Role in Public Health Emergency Response and Medical Countermeasure Development	Conference/Workshop	7/19/2021	New Drug Development	No
Where Do We Go from Here? How the Ombudsman Can Help	Conference/Workshop	7/19/2021	FDA Meetings/Communications	No
Communication Best Practices – Interacting with Regulatory Project Managers in CDER/ORO	Conference/Workshop	7/19/2021	FDA Meetings/Communications	No
Communications in a Global Pandemic	Conference/Workshop	7/19/2021	FDA Meetings/Communications	No
Regulatory Policy: Role in Guiding Decision Making in CDER	Conference/Workshop	7/19/2021	New Drug Development	No
Role of the Product Jurisdiction Team in the Medical Product Development Process	Conference/Workshop	7/19/2021	New Drug Development	No
FDA Guidance on Conduct of Clinical Trials of Medical Products During the Public Health Emergency	Conference/Workshop	7/19/2021	New Drug Development; Clinical Trials and Research	No
OSI’s Role in the Drug Development Process and Impact of COVID-19	Conference/Workshop	7/19/2021	New Drug Development	No
Safety Reporting Requirements and Safety Assessment for IND and BA/BE Studies	Webinar	6/29/2021	IND, Safety	No
Identification of Medicinal Products: Path to Global Implementation	Webinar	6/11/2021	International, Labeling, Regulatory Submissions	No
OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2021 User Fees Webinar	Webinar	6/3/2021	OTC Drug Regulation	No
FDA Study Data Technical Rejection Criteria (TRC): What you need to know!	Webinar	5/21/2021	Regulatory Submissions	No
FY 2021 Generic Drug Science and Research Initiatives Public Workshop	Conference/Workshop	6/23/2021	Generic Drug Development	No
Welcome, Keynote, and Industry Survey Results - GDUFA Science and Research Initiatives Public Workshop	Conference/Workshop	6/23/2021	Generic Drug Development	No
Generic Industry Challenge Perspectives - GDUFA Science and Research Initiatives Public Workshop	Conference/Workshop	6/23/2021	Generic Drug Development	No
Public Comment - GDUFA Science and Research Initiatives Public Workshop	Conference/Workshop	6/23/2021	Generic Drug Development	No
Panel Discussion with Generic Industry - GDUFA Science and Research Initiatives Public Workshop	Conference/Workshop	6/23/2021	Generic Drug Development	No
Model-Integrated Evidence for Generic Drug Development – Session 1A	Conference/Workshop	6/23/2021	Generic Drug Development	No
Model-Integrated Evidence for Generic Drug Development – Session 1B	Conference/Workshop	6/23/2021	Generic Drug Development	No
Model-Integrated Evidence for Generic Drug Development – Session 1C	Conference/Workshop	6/23/2021	Generic Drug Development	No
Complex Product Characterization/Analysis - Session 2A	Conference/Workshop	6/23/2021	Generic Drug Development	No
Complex Product Characterization/Analysis - Session 2B	Conference/Workshop	6/23/2021	Generic Drug Development	No
Complex Product Characterization/Analysis - Session 2C	Conference/Workshop	6/23/2021	Generic Drug Development	No
In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3A	Conference/Workshop	6/23/2021	Generic Drug Development	No
In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3B	Conference/Workshop	6/23/2021	Generic Drug Development	No
Closing Remarks - Robert Lioberger, PhD, Director, Office of Research and Standards (ORS), OGD, FDA	Conference/Workshop	6/23/2021	Generic Drug Development	No
FDA and Health Canada Regional ICH Consultation	Conference/Workshop	5/14/2021	Clinical Trials and Research; International; New Drug Development	No
FDA and Health Canada Regional ICH Consultation - Part I	Conference/Workshop	5/14/2021	Clinical Trials and Research; International; New Drug Development	No
FDA and Health Canada Regional ICH Consultation - Part II	Conference/Workshop	5/14/2021	Clinical Trials and Research; International; New Drug Development	No
Common Labeling Deficiencies and Tips for Generic Drug Applications	Webinar	5/7/2021	Generic Drug Development; Labeling	No
FDA Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs	Webinar	5/5/2021	Generic Drug Development; New Drug Development; Orange Book	No
Generic Drugs Forum 2021: Lifecycle of a Generic Drug	Conference/Workshop	4/28/2021	Generic Drug Development	No
Generic Drugs Forum 2021: Lifecycle of a Generic Drug: Keynote from Sally Choe, Director, Office of Generic Drugs (OGD)	Conference/Workshop	4/28/2021	Generic Drug Development	No
Office of Pharmaceutical Quality (OPQ) Update	Conference/Workshop	4/28/2021	Generic Drug Development; Drug Quality	No
Global Generic Drug Landscape	Conference/Workshop	4/28/2021	Generic Drug Development	No
Data Integrity Issues in Bioequivalence Studies	Conference/Workshop	4/28/2021	Generic Drug Development; Drug Quality	No
Bioavailability/Bioequivalence Site Evaluation During the Pandemic	Conference/Workshop	4/28/2021	Generic Drug Development	No
Impact of Data Integrity Issues on Pharmacology/Toxicology Studies in ANDAs	Conference/Workshop	4/28/2021	Generic Drug Development; Drug Quality	No
Generic Drugs Forum 2021: Panel Discussion 1	Conference/Workshop	4/28/2021	Generic Drug Development	No
OPQ Policy Update	Conference/Workshop	4/28/2021	Generic Drug Development; Drug Quality	No
Update on CDER’s Quality Management Maturity Program	Conference/Workshop	4/28/2021	Generic Drug Development	No
Generic Drugs Forum 2021: Panel Discussion 2	Conference/Workshop	4/28/2021	Generic Drug Development	No
Pre-ANDA Program	Conference/Workshop	4/28/2021	Generic Drug Development; FDA Meetings/Communications	No
Pre-ANDA Program Update and Tips for Success – OPQ Perspective	Conference/Workshop	4/28/2021	Generic Drug Development; Drug Quality	No
Controlled Correspondence Related to Pharmaceutical Quality	Conference/Workshop	4/28/2021	Generic Drug Development; FDA Meetings/Communications	No
Generic Drugs Forum 2021: Panel Discussion 3	Conference/Workshop	4/28/2021	Generic Drug Development	No
Division of Filing Review: Helpful Tips for Submission of an ANDA or Controlled Correspondence	Conference/Workshop	4/28/2021	Generic Drug Development	No
>ANDA Labeling: Recommendations and Helpful Resources	Conference/Workshop	4/28/2021	Generic Drug Development; Labeling	No
Generic Drugs Forum 2021: Panel Discussion 4	Conference/Workshop	4/28/2021	Generic Drug Development	No
Addressing Common Challenges in BE Studies Due to COVID-19: OGD’s Approach	Conference/Workshop	4/28/2021	Generic Drug Development	No
Insights from Records Requests under §704(a)(4) of the FD&C Act in lieu of Pre-Approval Inspections	Conference/Workshop	4/28/2021	Generic Drug Development	No
Generic Drugs Forum 2021: Panel Discussion 5	Conference/Workshop	4/28/2021	Generic Drug Development	No
Mid-Review Cycle Meeting Overview	Conference/Workshop	4/28/2021	Generic Drug Development; FDA Meetings/Communications	No
Information to Include with Cover Letters	Conference/Workshop	4/28/2021	Generic Drug Development; FDA Meetings/Communications	No
Application Communications – Quality Assessment Perspective	Conference/Workshop	4/28/2021	Generic Drug Development; Drug Quality	No
Generic Drugs Forum 2021: Panel Discussion 6	Conference/Workshop	4/28/2021	Generic Drug Development	No
Fostering Innovation Through OPQ’s Emerging Technology Program	Conference/Workshop	4/28/2021	Generic Drug Development	No
Lab Science to Support Generic Complex Drug Product Assessment	Conference/Workshop	4/28/2021	Generic Drug Development	No
Assessment of Extractables/Leachables Data in ANDA Submissions	Conference/Workshop	4/28/2021	Generic Drug Development; Drug Quality	No
Generic Drugs Forum 2021: Panel Discussion 7	Conference/Workshop	4/28/2021	Generic Drug Development	No
Biopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms	Conference/Workshop	4/28/2021	Generic Drug Development; Drug Quality	No
Integrated Manufacturing Assessment: Expectations	Conference/Workshop	4/28/2021	Generic Drug Development; Drug Quality	No
Building a Better Sterility Assurance Application	Conference/Workshop	4/28/2021	Generic Drug Development; Drug Quality	No
Generic Drugs Forum 2021: Panel Discussion 8	Conference/Workshop	4/28/2021	Generic Drug Development	No
Postmarketing Safety and Surveillance of Generic Drugs Update	Conference/Workshop	4/28/2021	Generic Drug Development	No
Premarket Review of Expedited Serious Adverse Event Reports of BA/BE Studies	Conference/Workshop	4/28/2021	Generic Drug Development; Safety	No
Update on Shared System REMS for Generic Drug	Conference/Workshop	4/28/2021	Generic Drug Development; Safety	No
ANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues	Conference/Workshop	4/28/2021	Generic Drug Development	No
Generic Drugs Forum 2021: Panel Discussion 9	Conference/Workshop	4/28/2021	Generic Drug Development	No
Drug Master File (DMF) and Drug Substance Question and Answer Webinar Following March 3-4, 2021 Workshop	Webinar	4/9/2021	Drug Master Files	No
FDA Safety Report Type Flag Requirement for FAERS Submissions	Webinar	2/19/2021	Regulatory Submissions; Safety	No
Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
Oncology Center of Excellence Introduction and Overview of the Oncology Therapy Development Workshop	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
Innovation Mindset – Advancing Science to Therapies	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
FDA Oncology Drug Development Overview – Past to Present	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
Federal Resources for Innovative Cancer Startups: More Than Just Funding	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
Best Practices for Venture Capital Fundraising: Learn How Early-stage VCs Think	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
Funding Sources Panel Discussion	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
Building Your Network and Value to Obtain External Input Prior to Interacting with FDA	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
Assembling the Best Team to Navigate through Preclinical Development	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
Consulting Companies and FDA Limitations Panel Discussion	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
CMC Considerations for CAR T Cell Product Development	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
CMC Considerations for Oncolytic Viral Product Development	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
Preclinical Considerations for Cell and Gene Therapy Products, an FDA Perspective	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
FDA’s Clinical Regulatory Perspective: Designing First-In-Human Trial for Cellular and Gene Therapy	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
Oncology Therapy Development Workshop Overview, Day Two	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
Chemistry and Manufacturing Requirements for Early Clinical Development: What’s in there? Prove it.	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
CMC Considerations for Biotechnology Product Development: A Regulatory Perspective	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
Getting to First-in-Human for Small Molecules and Biologics	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
Designing First-In-Human Trials for Small Molecules and Biologics	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
Planning for Co-development of Companion Diagnostics	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
Clinical Development of Radiopharmaceuticals a Theranostic Pairs and Dosimetry Considerations	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
Getting the Best Dose: The Clinical Pharmacology Studies that Help Achieve this Goal	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
Oncology Center of Excellence Introduction and Overview of the Oncology Therapy Development Workshop: Panel Discussion	Conference/Workshop	3/30/2021	New Drug Development; Clinical Trials and Research	No
Drug Master File (DMF) and Drug Substance Workshop	Webinar	3/3/2021	Drug Master Files	No
Regulatory Perspectives for Development of Drugs for Treatment of NASH	Webinar	1/29/2021	New Drug Development; Clinical Trials and Research	No
OTC Monograph Reform in the CARES Act: Safety Orders	Webinar	1/27/2021	OTC Drug Regulation	No
CDER Compliance Conference	Conference/Workshop	1/14/2021	Compliance, Import/Export; Compounding; DSCSA; Safety	No
Compounding: Cleanrooms and Cleanroom Behaviors: Why they Matter	Conference/Workshop	1/14/2021	Compliance, Import/Export; Compounding	No
Enhanced Drug Distribution Security – Drug Supply Chain Security Act (DSCSA) Implementation Updates	Conference/Workshop	1/14/2021	Compliance, DSCSA	No
A Glance at Drug Importation Requirements	Conference/Workshop	1/14/2021	Compliance, Import/Export; Compounding	No
Risk Evaluation and Mitigation Strategies (REMS) Compliance Program	Conference/Workshop	1/14/2021	Compliance, Safety	No
Drug Master File (DMF) Submissions on New FDA Form 3938	Webinar	1/13/2021	Drug Master File	No
Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA	Webinar	12/16/2020	Clinical Trials and Research	No
SEND for CBER, What You Need to Know	Webninar	12/4/2020	Regulatory Submissions	No
Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions	Webinar	11/20/2020	Generic Drug Development	No
Office of Prescription Drug Promotion - Core Launch Review Process	Webinar	11/20/2020	Marketing	No
Bridging the Gap – Promoting Safe and Effective Prescription Drug Use in Geriatric Patients	Webinar	11/13/2020	Labeling	No
Office of New Drug (OND) Research: Seeking Collaborators, Funding Opportunities Available	Webinar	11/6/2020	New Drug Development	No
Celebrating 40 Years: An In-Depth Examination of the FDA Orange Book	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
Opening Remarks and FDA's Orange Book: A Historical Review of 40 Years	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
Orange Book 101: An Overview of FDA's Orange Book	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
How to Update Orange Book Information	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
How to Update Orange Book Information – Panel Discussion	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
An Overview of FDA's Patent Listing Process	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
Changes to Orange Book Patent Information	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
Orange Book Patent Information – Panel Discussion	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
The Patent Information Dispute Process	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
Best Practices for 505(b)(2) and ANDA Applicants	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
Patent Dispute and Best Practices for 505(b)(2) and ANDA Applicants – Panel Discussion	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
Orange Book Exclusivity: An Introduction and Overview	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
Orange Book Exclusivity: Part I - NCE and 3-Year	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
Orange Book Exclusivity – Panel Discussion	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
Orange Book Exclusivity: Part II - Pediatric, Orphan, and GAIN	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
Orange Book Exclusivity: Part III - 180-Day and Competitive Generic Therapy Exclusivities	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
Orange Book Exclusivity – Panel Discussion	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
Orange Book: An Overview of Therapeutic Equivalence	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
Referencing Approved Drug Products in ANDA Submissions	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
Orange Book: Looking Towards the Future	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
Closing Remarks	Conference/Workshop	10/27/2020	Generic Drug Development; New Drug Development; Orange Book	No
New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment	Webinar	10/15/2020	Drug Development; Clinical Trials and Research	No
Drug Registration and Listing Workshop	Conference/Workshop	10/8/2020	Registration and Listing	No
Drug Registration and Listing Workshop: Labeler Code Request	Conference/Workshop	10/8/2020	Registration and Listing	No
Drug Registration and Listing Workshop: Establishment Registration	Conference/Workshop	10/8/2020	Registration and Listing	No
Drug Registration and Listing Workshop: Drug Listing	Conference/Workshop	10/8/2020	Registration and Listing	No
Drug Registration and Listing Workshop: 503B Compounder Product Reporting Using CDERDirect	Conference/Workshop	10/8/2020	Registration and Listing	No
Drug Registration and Listing Workshop: Establishment Registration and Drug Listing Compliance Program	Conference/Workshop	10/8/2020	Registration and Listing	No
Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs	Webinar	10/2/2020	Drug Quality	No
Advancing Innovative Science in Generic Drug Development Workshop	Conference/Workshop	9/29/2020	Generic Drug Development	No
Dr. Hahn's Remarks to “Advancing Innovative Science in Generic Drug Development” Workshop 9/29/2020	Conference/Workshop	9/29/2020	Generic Drug Development	No
Update on GDUFA Science and Research	Conference/Workshop	9/29/2020	Generic Drug Development	No
March 2020 Transition Under the BPCI Act: Impact on Generics	Conference/Workshop	9/29/2020	Generic Drug Development	No
Related Impurities Assessment Considerations for APIs in the Generic Complex Peptide Products	Conference/Workshop	9/29/2020	Generic Drug Development	No
Non-clinical Evaluation of Immunogenicity Risk of Generic Complex Peptide Products	Conference/Workshop	9/29/2020	Generic Drug Development	No
Panel Discussion on Method Development / Validations for Non-traditional Analytical Methods	Conference/Workshop	9/29/2020	Generic Drug Development	No
Developing and Validating Advanced Microscopy Methods for Supporting Complex Product Equivalence	Conference/Workshop	9/29/2020	Generic Drug Development	No
Developing & Validating Commonly Employed Particle Sizing Methods to Support BE and Product Quality	Conference/Workshop	9/29/2020	Generic Drug Development	No
Quantitative Methods for Determining Equivalence of Particle Size Distributions	Conference/Workshop	9/29/2020	Generic Drug Development	No
Panel for Advanced Analytical and Statistical Methods for Assessing Particle Size Distributions	Conference/Workshop	9/29/2020	Generic Drug Development	No
Assessment of Complex Drug Product – Physicochemical Characteristics to Support In Vitro BE Studies	Conference/Workshop	9/29/2020	Generic Drug Development	No
In Vitro Release Testing for Complex Generics: A Bioequivalence Perspective	Conference/Workshop	9/29/2020	Generic Drug Development	No
In Vitro Bioequivalence Studies of Topical Drug Products: Challenges and Promises of IVRT and IVPT	Conference/Workshop	9/29/2020	Generic Drug Development	No
Panel on Development and Validation Considerations for Drug Release and Permeation Testing	Conference/Workshop	9/29/2020	Generic Drug Development	No
Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness	Conference/Workshop	9/29/2020	Generic Drug Development	No
Calculating Maximum Daily Dose (MDD) for Orally Administered Drug Products	Conference/Workshop	9/29/2020	Generic Drug Development	No
What’s New in the Inactive Ingredient Database (IID)?	Conference/Workshop	9/29/2020	Generic Drug Development	No
Local Toxicity Considerations for Qualifying Excipients in Generic Drugs	Conference/Workshop	9/29/2020	Generic Drug Development	No
Panel on Excipient and Formulation Considerations	Conference/Workshop	9/29/2020	Generic Drug Development	No
In Vitro Studies for Alternative BE Approaches to Comparative Clinical Endpoint BE Studies	Conference/Workshop	9/29/2020	Generic Drug Development	No
The Potential of PK BE Studies in Detecting Regional Deposition with Orally Inhaled Drugs	Conference/Workshop	9/29/2020	Generic Drug Development	No
Regional Deposition and Systemic Pharmacokinetic Data of OINDPs with Modeling and Simulation	Conference/Workshop	9/29/2020	Generic Drug Development	No
Panel on Future Directions, Emerging Technology, and Current Thinking on Alternative BE Approaches	Conference/Workshop	9/29/2020	Generic Drug Development	No
Topical Dosage Forms: Emerging Insights and Implications for Bioequivalence Approaches	Conference/Workshop	9/29/2020	Generic Drug Development	No
In Vivo Dermal Microperfusion & Microdialysis Bioequivalence Approaches	Conference/Workshop	9/29/2020	Generic Drug Development	No
Non-Invasive Raman Spectroscopy-Based Bioequivalence Approaches	Conference/Workshop	9/29/2020	Generic Drug Development	No
Panel on Topical Dermatologic Products	Conference/Workshop	9/29/2020	Generic Drug Development	No
PBPK to Guide Study Design and Product Development for Generic Dermatological Products	Conference/Workshop	9/29/2020	Generic Drug Development	No
Model-Informed and Model-Integrated Approach in BE Assessment of Long-Acting Injectable Products	Conference/Workshop	9/29/2020	Generic Drug Development	No
Panel on Emerging Use of Modeling and Simulation for Bioequivalence	Conference/Workshop	9/29/2020	Generic Drug Development	No
Biopharmaceutics Classification System Class 3 Waiver	Conference/Workshop	9/29/2020	Generic Drug Development	No
Using PBPK Absorption Modeling to Support Biopharmaceutics Classification System Class 3 Drug Waiver	Conference/Workshop	9/29/2020	Generic Drug Development	No
Alternatives to f2 Testing for Dissolution Similarity – f2 Bootstrapping and MSD Method	Conference/Workshop	9/29/2020	Generic Drug Development	No
Panel on Practical Considerations in the Study Design and Data Evaluation Recommended in PSGs	Conference/Workshop	9/29/2020	Generic Drug Development	No
A Closer Look into the Nasogastric and Gastric Feeding Tube Study Recommendations	Conference/Workshop	9/29/2020	Generic Drug Development	No
In Vitro Enteral (Nasogastric and Gastric) Feeding Tube Testing of Generic Drugs: Case Studies	Conference/Workshop	9/29/2020	Generic Drug Development	No
Practical Considerations for Bioequivalence of GI Locally-Acting Products	Conference/Workshop	9/29/2020	Generic Drug Development	No
Panel on In Vitro Feeding Tube Testing and GI Locally-Acting Products	Conference/Workshop	9/29/2020	Generic Drug Development	No
Cannabis Clinical Research: Drug Master Files (DMFs) & Quality Considerations	Webinar	9/16/2020	Drug Master Files	No
Real-world Evidence for Drugs, Biologics, and Devices - REdI 2020	Conference/Workshop	8/25/2020	New Drug Development; Real World Evidence; Postapproval	No
Restructure of the Office of New Drugs (OND) - REdI 2020	Conference/Workshop	8/25/2020	New Drug Development; NDA; Postapproval	No
So, Your NDA Was Approved – Now What?! Post-approval Responsibilities and Obligations- REdI 2020	Conference/Workshop	8/25/2020	New Drug Development; NDA; Postapproval	No
Overview of Postmarketing Drug Safety Reporting Requirements - REdI 2020	Conference/Workshop	8/25/2020	New Drug Development; NDA; Postapproval; Safety	No
Drug Shortages - REdI 2020	Conference/Workshop	8/25/2020	New Drug Development; NDA; Postapproval; Drug Shortages	No
Enhanced Drug Distribution Security – DSCSA Implementation Updates - REdI 2020	Conference/Workshop	8/25/2020	New Drug Development; NDA; Postapproval; DSCSA	No
CDER Export Certificate Program - REdI 2020	Conference/Workshop	8/25/2020	New Drug Development; NDA; Postapproval; Import/Export	No
SBIA Program Overview - REdI 2020	Conference/Workshop	8/25/2020	New Drug Development; NDA; Postapproval; Resources	No
Post-Approval Submission of Promotional Materials to the OPDP - REdI 2020	Conference/Workshop	8/25/2020	New Drug Development; NDA; Postapproval; Marketing	No
Requirement for Electronic Submission of an Application and Study Data - REdI 2020	Conference/Workshop	8/25/2020	New Drug Development; NDA; Postapproval; Regulatory Submissions	No
Overview of Post-approval Chemistry, Manufacture, and Controls (CMC) Changes to an NDA - REdI 2020	Conference/Workshop	8/25/2020	New Drug Development; NDA; Postapproval; Drug Quality	No
Lifecycle Changes to Chemistry, Manufacture, and Controls in NDAs - REdI 2020	Conference/Workshop	8/25/2020	New Drug Development; NDA; Postapproval; Drug Quality	No
Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020	Conference/Workshop	8/25/2020	New Drug Development; NDA; Postapproval; Drug Quality	No
Questions and Panel Discussion – Post-approval CMC and Manufacturing - REdI 2020	Conference/Workshop	8/25/2020	New Drug Development; NDA; Postapproval; Drug Quality	No
FDA Drug Manufacturing Inspections - REdI 2020	Conference/Workshop	8/25/2020	New Drug Development; NDA; Postapproval; Inspections	No
Bioanalysis of Endogenous Compounds in PK BE Studies in ANDAs - Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
Bioanalysis of the Dried Blood Spot (DBS) by Mass Spectrometry for Clinical Studies -Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
Bioanalysis of Unstable Analytes in Pharmacokinetic BE Studies for ANDAs - Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
Bioanalytical Method Validation: History, Process, and Regulatory Perspectives - Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
Case Study: Bioanalytical Approaches to Mitigate Issues during a BE Inspection - Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
Common Deficiencies for Study Sample Reanalysis in PK BE for ANDAs - Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
Considerations on ex vivo Conversion of Prodrugs during Bioanalysis - Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
CREST Site Selection Model Overview - Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
Keynote - Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
Office of Clinical Pharmacology (OCP): Biosimilars - Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
Office of Clinical Pharmacology (OCP): Drugs and Biologics - Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
Office of Clinical Pharmacology (OCP): Panel Discussion - Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
Office of Generic Drugs Panel Discussion - Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
Office of Study Integrity and Surveillance Session (OSIS) Panel Discussion - Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
Overview of Immunogenicity Inspections - Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
Panel Discussion - Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
Regulated Bioanalysis for Small Molecules - Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
Regulated Bioanalysis of Large Molecules - Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
Regulatory Education for Industry: Regulated Bioanalysis Workshop: Requirements and Expectations	Conference/Workshop	6/30/2020	Generic Drug Development	No
What Meta-analysis Can Tell You about the Performance of Bioanalytical Methods - Bioanalysis	Conference/Workshop	6/30/2020	Generic Drug Development	No
Keynote: Pharmaceutical Quality: A Global Priority (CDER) (1/15) Global Quality	Webinar	7/23/2020	Drug Quality; International	No
An International Commitment to Pharmaceutical Quality (2/15) Global Quality	Webinar	7/23/2020	Drug Quality; International	No
Manufacturing Assessment and Application Action (3/15) Global Quality	Webinar	7/23/2020	Drug Quality; International	No
Pre-Approval Inspections and Alternative Approaches to Facility Assessment (4/15) Global Quality	Webinar	7/23/2020	Drug Quality; Inspections; International	No
An Overview of Pre-License Inspections for Biotech Products (5/15) Global Quality	Webinar	7/23/2020	Drug Quality; Inspections; International	No
Panel Discussion (6/15) Global Quality	Webinar	7/23/2020	Drug Quality; Inspections; International	No
FDA’s International Mission and the Global Manufacturing Landscape (7/15) Global Quality	Webinar	7/23/2020	Drug Quality; International	No
Quality Management Maturity: FDA Vision & Expectations (8/15) Global Quality	Webinar	7/23/2020	Drug Quality; International	No
Major Issues and Facilities in Drug Master Files (9/15) Global Quality	Webinar	7/23/2020	Drug Quality; Drug Master Files; International	No
Pharmaceutical Quality Policies: What You Need to Know (10/15) Global Quality	Webinar	7/23/2020	Drug Quality; International	No
Panel Discussion (11/15) Global Quality	Webinar	7/23/2020	Drug Quality; Drug Master Files; International	No
FDA’s International Office and the Pharmaceutical Quality Mission (12/15) Global Quality	Webinar	7/23/2020	Drug Quality; International	No
The State of Pharmaceutical Quality: Surveillance Findings (13/15) Global Quality	Webinar	7/23/2020	Drug Quality; International	No
Successfully Implementing Advanced Manufacturing (14/15) Global Quality	Webinar	7/23/2020	Drug Quality; International	No
Panel Discussion (15/15) Global Quality	Webinar	7/23/2020	Drug Quality; International	No
A Pharmaceutical Quality Webinar for Global Stakeholders	Webinar	7/23/2020	Drug Quality; International	No
CDER SEND Common Issues and Policy Update	Webinar	6/15/2020	Regulatory Submissions	No
Best Practices for Proprietary Name Design – Pharmacovigilance	Conference/Workshop	6/9/2020	Safety	No
Combination Products: Reporting Device Information and Malfunctions - Pharmacovigilance	Conference/Workshop	6/9/2020	Safety	No
Considerations for REMS Surveys and Assessments: Planning and Reporting - Pharmacovigilance	Conference/Workshop	6/9/2020	Safety	No
Designing User Interfaces to Prevent Medication Errors – Pharmacovigilance	Conference/Workshop	6/9/2020	Safety	No
Development of Shared System REMS & Implications of the Appropriations Act - Pharmacovigilance	Conference/Workshop	6/9/2020	Safety	No
Digital IND Safety Reporting - Pharmacovigilance	Conference/Workshop	6/9/2020	Safety; IND	No
Division of Risk Management: Overview of Review Activities and REMS - Pharmacovigilance	Conference/Workshop	6/9/2020	Safety	No
FDA Adverse Event Reporting System (FAERS) Overview - Pharmacovigilance	Conference/Workshop	6/9/2020	Safety	No
FDA's Sentinel Initiative - Pharmacovigilance	Conference/Workshop	6/9/2020	Safety	No
ICSR Data Quality of Coding: Products, Adverse Events and Medication Errors - Pharmacovigilance	Conference/Workshop	6/9/2020	Safety	No
Keynote – Pharmacovigilance and Risk Management Conference	Conference/Workshop	6/9/2020	Safety	No
Postmarket Safety Surveillance: Tools, Methods, and Benefit-Risk Framework - Pharmacovigilance	Conference/Workshop	6/9/2020	Safety	No
Preventing Medication Errors: Lessons Learned from Postmarket Safety Surveillance– Pharmacovigilance	Conference/Workshop	6/9/2020	Safety	No
Process for Reviewing Nonproprietary Name Suffix for Biological Products – Pharmacovigilance	Conference/Workshop	6/9/2020	Safety	No
Questions and Discussion – Pharmacovigilance	Conference/Workshop	6/9/2020	Safety	No
REMS Integration Initiatives - Pharmacovigilance	Conference/Workshop	6/9/2020	Safety	No
Pharmacovigilance and Risk Management Conference – New Approaches, Tools, and Technologies	Conference/Workshop	6/9/2020	Drug Development; Drug Safety	No
Monograph reform is here! Learn what to expect and how to prepare.	Webinar	5/29/2020	Regulatory Submissions; OTC Drug Regulation	No
Still submitting paper to CDER? Send electronically with CDER’s NextGen Portal instead!	Webinar	5/26/2020	Regulatory Submissions	No
Conducting Clinical Trials During the COVID-19 Public Health Emergency	Webinar	4/30/2020	New Drug Development	No
Postmarketing Drug Safety Compliance: 2019 Inspection Findings	Webinar	4/29/2020	Safety; Inspections	No
Updates on FDA’s Drug-Drug Interaction Final Guidances	Webinar	4/24/2020	New Drug Development; IND	No
Generic Drugs Forum - April 15&16, 2020	Conference/Workshop	4/15/2020	Generic Drug Development; Drug Quality	No
ANDA Program Performance Review and Tips (8/16) Generic Drugs Forum	Conference/Workshop	4/15/2020	Generic Drug Development; Drug Quality	No
Application Case Studies on FDA’s Action Letter Timing (16/16) Generic Drugs Forum	Conference/Workshop	4/15/2020	Generic Drug Development; Drug Quality	No
Common CMC (Quality) Issues and How to Avoid Them Part I (12/16) Generic Drugs Forum	Conference/Workshop	4/15/2020	Generic Drug Development; Drug Quality	No
Common CMC (Quality) Issues and How to Avoid Them Part II (14/16) Generic Drugs Forum	Conference/Workshop	4/15/2020	Generic Drug Development; Drug Quality	No
Current Global Generic Drug Landscape (10/16) Generic Drugs Forum	Conference/Workshop	4/15/2020	Generic Drug Development; Drug Quality	No
Electronic Submission of an ANDA Application and Study Data (7/16) Generic Drugs Forum	Conference/Workshop	4/15/2020	Generic Drug Development; Drug Quality	No
Facility Readiness: GMPs, Quality Assessments, and Compliance Trends (15/16) Generic Drugs Forum	Conference/Workshop	4/15/2020	Generic Drug Development; Drug Quality	No
Generic Combination Products: Assessment and Regulatory Update (14/16) Generic Drugs Forum	Conference/Workshop	4/15/2020	Generic Drug Development; Drug Quality	No
Generic Drug Labeling: Recommendations for High-Quality Submissions (4/28) Generic Drugs Forum	Conference/Workshop	4/15/2020	Generic Drug Development; Drug Quality	No
ICH Q12 Guidance and Emerging Technology Program (11/16) Generic Drugs Forum	Conference/Workshop	4/15/2020	Generic Drug Development; Drug Quality	No
Keynote from the Office of Pharmaceutical Quality (OPQ) (2/16) Generic Drugs Forum	Conference/Workshop	4/15/2020	Generic Drug Development; Drug Quality	No
Keynote: Generic Drug Program Update (1/16) Generic Drugs Forum	Conference/Workshop	4/15/2020	Generic Drug Development; Drug Quality	No
New Programs and Requirements Under FDARA (5/16) Generic Drugs Forum	Conference/Workshop	4/15/2020	Generic Drug Development; Drug Quality	No
Pre-ANDA Interactions with the FDA (6/16) Generic Drugs Forum	Conference/Workshop	4/15/2020	Generic Drug Development; Drug Quality	No
Product Specific Guidances (PSGs) (3/16) Generic Drugs Forum	Conference/Workshop	4/15/2020	Generic Drug Development; Drug Quality	No
The Importance of Generic Drug Pharmacovigilance (9/16) Generic Drugs Forum	Conference/Workshop	4/15/2020	Generic Drug Development; Drug Quality	No
Learn About ClinicalTrials.gov Modernization and How to Provide Input	Webinar	3/6/2020	Clinical Trials and Research	No
Recent Revisions to the ANDA Prioritization MAPP	Webinar	1/30/2020	Generic Drug Development	No
Improving Regulatory Communication via the CDER NextGen Portal	SBIA Chronicles Podcast	12/29/2019	Regulatory Submissions	No
Improving Regulatory Communication via the CDER NextGen Portal	SBIA Chronicles	12/19/2019	Regulatory Submissions	No
2019 CDER Prescription Drug Labeling Conference - December 4-5, 2019	Conference/Workshop	12/4/2019	New Drug Development; Labeling	No
A Recipe for Clinical Pharmacology Information in Labeling (1/19)	Conference/Workshop	12/4/2019	Labeling	No
Adverse Reaction Information in Prescribing Information (3/19)	Conference/Workshop	12/4/2019	Labeling	No
Drug Product Nomenclature (15/19)	Conference/Workshop	12/4/2019	Labeling	No
Improving the Accuracy of SPL Submissions “The Missing LOINC” (9/19)	Conference/Workshop	12/4/2019	Labeling	No
Indications and Usage & Drug Abuse and Dependence Sections of Labeling (2/19)	Conference/Workshop	12/4/2019	Labeling	No
Instructions for Use (IFU) Content and Format Draft Guidance (13/19)	Conference/Workshop	12/4/2019	Labeling	No
Labeling Case Study: Transformation of an Indication (6/19)	Conference/Workshop	12/4/2019	Labeling	No
Labeling Finalization: Final Check of Prescribing Information (8/19)	Conference/Workshop	12/4/2019	Labeling	No
Labeling for Biological Products (11/19)	Conference/Workshop	12/4/2019	Labeling	No
Panel Questions and Discussion (10/19)	Conference/Workshop	12/4/2019	Labeling	No
Panel Questions and Discussion (16/19)	Conference/Workshop	12/4/2019	Labeling	No
Panel Questions and Discussion (19/19)	Conference/Workshop	12/4/2019	Labeling	No
Panel Questions and Discussion (7/19)	Conference/Workshop	12/4/2019	Labeling	No
Pediatric Information In Prescribing Information (4/19)	Conference/Workshop	12/4/2019	Labeling	No
Prescribing Information and Carton/Container Labeling Consistency (18/19)	Conference/Workshop	12/4/2019	Labeling	No
Product Title & Initial US Approval in the Highlights Section (14/19)	Conference/Workshop	12/4/2019	Labeling	No
Safety Considerations for Container Labels and Carton Labeling (17/19)	Conference/Workshop	12/4/2019	Labeling	No
The Pregnancy and Lactation Labeling Rule: Four Years In — What’s next? (5/19)	Conference/Workshop	12/4/2019	Labeling	No
Voluntary PLR Conversions and Updating Prescribing Information (1/19)	Conference/Workshop	12/4/2019	Labeling	No
2019 CDER Prescription Drug Labeling Conference	Conference/Workshop	12/4/2019	Labeling	No
FDA Study Data Technical Conformance Guide v4.4	Webinar	11/22/2019	Regulatory Submissions	No
Clinical Investigator Training Course	Conference/Workshop	11/12/2019	New Drug Development	No
Technical Specifications for Submitting Data for QT Studies	Webinar	11/8/2019	Regulatory Submissions	No
Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS)	Webinar	11/1/2019	Safety; IND; Regulatory Submissions	No
OPDP Electronic Submissions – Common Errors in eCTD and How to Avoid Them	Webinar	10/25/2019	Regulatory Submissions; Marketing	No
Compliance Program and Case Study (7/8) Registration and Listing	Conference/Workshop	10/22/2019	Registration and Listing	No
Electronic Drug Registration and Listing Using CDER Direct	Conference/Workshop	10/22/2019	Registration and Listing	No
Establishment Registration and Labeler Code Requests (3/8) Registration and Listing	Conference/Workshop	10/22/2019	Registration and Listing	No
Keynote from the Drug Registration and Listing Staff (2/8) Registration and Listing	Conference/Workshop	10/22/2019	Registration and Listing	No
Listing Certification and Inactivation (6/8) Registration and Listing	Conference/Workshop	10/22/2019	Registration and Listing	No
NDC Reservation, Listing, 503B Compounded Product (5/8) Registration and Listing	Conference/Workshop	10/22/2019	Registration and Listing	No
Panel Questions and Discussion (4/8) Drug Registration and Listing Using CDER Direct	Conference/Workshop	10/22/2019	Registration and Listing	No
Panel Questions and Discussion (8/8) Registration and Listing	Conference/Workshop	10/22/2019	Registration and Listing	No
Welcome from CDER’s Office of Compliance (1/8) Registration and Listing	Conference/Workshop	10/22/2019	Registration and Listing	No
Application Manufacturing Assessment (4/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Assessment of the Multi-Attribute Method (MAM) Substance (23/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Biosimilars and Interchangeables - Regulatory Highlights (27/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Case Studies: Continuous Manufacturing of Drug Substance (21/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Change Management: ICH Q12 and Established Conditions (12/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Continuous Manufacturing of Drug Product (20/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Data Quality Expectations for Biosimilars with Case Studies (29/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Emerging Technology Program (18/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
End-to-end Integrated Continuous Manufacturing (25/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
FDA Perspectives on Biosimilar BLA-Manufacturing (28/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
FDA Research Supporting Emerging Technologies with Case Studies (24/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
FDA’s Quality Assessment and Knowledge Management - KASA (11/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
How Does FDA Execute Pre- and Post-approval Inspections? (7/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Integration of Assessment and Inspection for Biological Products (9/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Keynote: CDER’s Commitment to Pharmaceutical Quality (1/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Panel Questions and Discussion (10/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Panel Questions and Discussion (13/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Panel Questions and Discussion (17/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Panel Questions and Discussion (22/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Panel Questions and Discussion (26/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Panel Questions and Discussion (30/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Panel Questions and Discussion (33/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Panel Questions and Discussion (6/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Pharmaceutical Quality Surveillance Program (14/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Pharmaceutical Quality Symposium	Conference/Workshop	10/16/2019	Drug Quality	No
Policy Considerations for Continuous Manufacturing (19/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Policy Initiatives for Pharmaceutical Quality (5/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Quality Assessment of BLAs, NDAs, and ANDAs (3/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Quality Considerations for Transition Biological Products (32/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Quality Metrics, Quality Culture, and Data-Driven Decisions (16/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Quality-Related Compliance Actions and Trends (15/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Small Molecule Case Studies (8/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
The “Deemed to be a License” Provision of the BPCI Act (31/33) Quality	Conference/Workshop	10/16/2019	Drug Quality; Biosimilars; BLA; NDA	No
The Importance of Quality in Our Medicines (2/33) Quality	Conference/Workshop	10/16/2019	Drug Quality	No
Electronic Submission of Adverse Event Reports to FDA Adverse Event Reporting System (FAERS) using International Council for Harmonisation (ICH) E2B(R3) Standards	Webinar	10/11/2019	Regulatory Submissions; Safety	No
2019 Complex Generic Drug Product Development Workshop	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
BE Approaches for Long Acting Drug Products (14/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
BE for Bridging Studies with Orally Inhaled/Nasal Drugs (26/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Bioequivalence for Generic Topical and Transdermal (6/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
CMC Updates for Orally Inhaled Drugs (27/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Comparative Analyses: Device and User Interface (25/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Comparative Analyses: Injectable Combination Products (21/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Complex Peptide ANDAs: Test/Reference Comparability (11/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Considerations of Particle Analysis (12/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
CREdIbility for Computational Fluid Dynamics Models (33/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Dose-Scale Analysis in Pharmacodynamic Equivalence (31/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
FDA’s Inactive IngREdIent Database (IID) (3/f35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Generic Topical and Transdermal Products (5/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
In Vitro Drug Release Testing for LA Drug Products QC (16/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Keynote with Sally Choe (1/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Overview of Comparative Analyses - Clinical Perspective (19/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Panel Questions and Discussion (35/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Physiologically-based Pharmacokinetic Modeling (32/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
PK/PD Meta-analysis of Abuse Deterrent Opioid Drugs (30/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Pre-ANDA Meeting Requests for Orally Inhaled/Nasal Drugs(24/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Pre-ANDA Program Update (2/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
PSG Recommendations and Updates for OINDPs (23/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Quality for Transdermal Delivery Systems (8/35) Complex Generic Drugs	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Quality View on Injectable Product Considerations (20/35) Complex Generic Drugs	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Quantitative Clinical Pharmacology in LA Injectables (34/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Quantitative Methods and Modeling (29/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Questions and Answers (13/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Questions and Answers (17/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Questions and Answers (22/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Questions and Answers (28/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Questions and Answers (4/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Questions and Answers (9/35) Complex Generic Drugs	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Strategies for Generic Topical Product Development (7/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Strategies to Demonstrate Complex API Sameness (10/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
Strategies to Demonstrate Complex Excipient Sameness (15/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
What Constitutes Complex Drug-Device Combination (18/35) Complex Generics	Conference/Workshop	9/25/2019	Generic Drug Development; Drug Quality	No
REdI and CERSI Workshop: Current State and Future Expectations of Translational Modeling Strategies to Support Drug Product Development, Manufacturing Changes and Controls	Conference/Workshop	9/23/2019	New Drug Development	No
Abbreviated Approval Pathways - 505(b)(2) or ANDA?	SBIA Chronicles	9/19/2019	Generic Drug Development; NDA	No
Abbreviated Approval Pathways - 505(b)(2) or ANDA?	SBIA Chronicles Podcast	9/19/2019	Generic Drug Development; NDA	No
Most Common Issues with CDISC-SEND Data in FDA Toxicology Review	Webinar	9/12/2019	Regulatory Submissions	No
eCTD Submissions of Promotional Labeling and Advertising Materials	Webinar	8/12/2019	Regulatory Submissions; Marketing	No
Risk-Based Approach to Monitoring Clinical Investigations: Overview of FDA Draft Guidance Issued for Comment	Webinar	6/26/2019	Clinical Trials and Research	No
Research Investigational New Drug Applications – What You Need To Know	SBIA Chronicles	6/25/2019	Clinical Trials and Research; IND	No
Research Investigational New Drug Applications – What You Need To Know	SBIA Chronicles Podcast	6/25/2019	Clinical Trials and Research; IND	No
Bioanalytical Method Validation of ANDAs – What the Assessor Looks for During Inspections	Webinar	6/17/2019	Generic Drug Development	No
Accuracy and Precision in Bioanalysis: Review of Case Studies	Webinar	6/17/2019	New Drug Development	No
Bioanalytical Method Validation (BMV) Panel Discussion	Webinar	6/17/2019	New Drug Development	No
Bioanalytical Inspections: Overview and Case Studies	Webinar	6/17/2019	New Drug Development	No
How should I measure this? An FDA perspective on the Bioanalytical Method Validation (BMV)	Webinar	6/17/2019	New Drug Development	No
The Finalized Bioanalytical Method Validation Guidance: What’s New For NDAs and BLAs	Webinar	6/17/2019	New Drug Development; NDA; BLA	No
Identification of Medicinal Products (IDMP): What is IDMP and Why Should I Care?	Webinar	6/13/2019	New Drug Development	No
CDER FDA Exclusivity – Which One Is for Me?	Webinar	6/10/2019	User Fees; NDA; BLA	No
FDA Orphan Drugs Program and Financial Incentives for CDER Medical Products	Webinar	6/10/2019	User Fees; NDA; BLA	No
Financial Incentives for CDER Medical Products	Webinar	6/10/2019	User Fees; NDA; BLA	No
Navigating the World of Biosimilar User Fees	Webinar	6/10/2019	BLA; User Fees	No
Panel on Financial Incentives for CDER Medical Products - PDUFA & Biosimilars	Webinar	6/10/2019	User Fees; NDA; BLA	No
Prescription Drug User Fee Act Waivers, Exemptions, and Refunds -Oh My	Webinar	6/10/2019	User Fees; NDA; BLA	No
A Medical Officer’s Approach to NDA/BLA Review (8/15) REdI Annual Conference	Conference/Workshop	5/29/2019	New Drug Development; IND; Resources	No
CDER Industry Assistance Resources (1/15) REdI	Conference/Workshop	5/29/2019	New Drug Development; IND; Resources	No
CDER’s Review of the Prescribing Information (11/15) REdI– May 29-30, 2019	Conference/Workshop	5/29/2019	New Drug Development; IND	No
CMC - NDA requirements and Common Pitfalls of BLAs (14/15) REdI	Conference/Workshop	5/29/2019	New Drug Development; IND	No
Components of New Drug Application and Biologics License Application (5/15) REdI	Conference/Workshop	5/29/2019	New Drug Development; IND	No
Electronic Common Technical Document (eCTD) and Study Data (7/15) REdI	Conference/Workshop	5/29/2019	New Drug Development; IND	No
Meetings: Pre-submission and Special Programs (4/15) REdI Annual Conference	Conference/Workshop	5/29/2019	New Drug Development; IND	No
Navigating the World of Combination Products (2/15) REdI	Conference/Workshop	5/29/2019	New Drug Development; IND	No
NDA and BLA Application Review Process (6/15) REdI Annual Conference	Conference/Workshop	5/29/2019	New Drug Development; IND	No
Nonproprietary Name Suffix and Safety for Product Design and Labels (10/15) REdI	Conference/Workshop	5/29/2019	New Drug Development; IND	No
ORA Aligned for the Future (1/15) REdI	Conference/Workshop	5/29/2019	New Drug Development; IND	No
Pre-Approval Inspections: What to Expect When Being Inspected (15/15) REdI	Conference/Workshop	5/29/2019	New Drug Development; IND; Inspections	No
Ready to Launch: Essentials of Submitting Initial Materials to OPDP (12/15) REdI	Conference/Workshop	5/29/2019	New Drug Development; IND; Marketing	No
Regulatory Education for Industry (REdI) Annual Conference - Focus on Essentials of NDAs and BLAs	Conference/Workshop	5/29/2019	User Fees; NDA; BLA	No
Regulatory Highlights for Biosimilars and Interchangeables (9/15) REdI	Conference/Workshop	5/29/2019	New Drug Development; IND	No
What can CDER do for you? (3/15) REdI Annual Conference	Conference/Workshop	5/29/2019	New Drug Development; IND	No
Competitive Generic Therapies	SBIA Chronicles	5/23/2019	Generic Drug Development	No
Competitive Generic Therapies	SBIA Chronicles Podcast	5/23/2019	Generic Drug Development	No
An Introduction to FDA MyStudies: An Open-Source, Digital Platform to Gather Real World Data for Clinical Trials and Research Studies	Webinar	5/9/2019	Clinical Trials and Research	No
Deploying the MyStudies System in a Compliant Manner (8/9) MyStudies App	Webinar	5/9/2019	New Drug Development; Real World Evidence	No
Final Question and Answer Panel (9/9) MyStudies App	Webinar	5/9/2019	New Drug Development; Real World Evidence	No
Introduction (1/9) FDA MyStudies Mobile App System	Webinar	5/9/2019	New Drug Development; Real World Evidence	No
Mobile Application and WCP: Usability and Technical Overview (5/9) FDA MyStudies App	Webinar	5/9/2019	New Drug Development; Real World Evidence	No
Patient and Researcher Experiences: A Demonstration (2/9) FDA MyStudies App	Webinar	5/9/2019	New Drug Development; Real World Evidence	No
Patient and Researcher Experiences: Demo of the FDA MyStudies Mobile App (3/9)	Webinar	5/9/2019	New Drug Development; Real World Evidence	No
Question and Answer Panel (7/9) MyStudies App	Webinar	5/9/2019	New Drug Development; Real World Evidence	No
Question and Answer Session Martin and Wyner (4/9) FDA MyStudies App	Webinar	5/9/2019	New Drug Development; Real World Evidence	No
Response Server Technical Overview (6/9) FDA MyStudies App	Webinar	5/9/2019	New Drug Development; Real World Evidence	No
505(b)(2) NDA or ANDA? (10/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Assessment Tips (17/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Case Studies: Inadequate Bioequivalence Studies (18/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Complex Product Development (3/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Continuous Manufacturing with a Generic Perspective (25/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Decrease RTR, IR, and CR Due to Dissolution Deficiencies (21/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Deficiencies and Observations from Facility Evaluations and Inspections(27/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Drug Master Files (DMFs) from an ANDA Perspective (7/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Filing and Refuse to Receive (RTR) (16/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Generic Drug Forum: April 3-4, 2019	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Impurity Case Studies: Pharmacology/Toxicology (22/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Keynote: Generic Drug Program Update (1/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Manufacturing Process and Controls: Avoiding Assessment Issues (26/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Mid-cycle Assessment and Post-complete Response Letter Meetings (6/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Orange Book - Its Role in ANDAs (8/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Practical Tips on eCTD (13/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Pre-ANDA Meeting or Controlled Correspondence? (4/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Questions and Answers (11/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Questions and Answers (15/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Questions and Answers (19/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Questions and Answers (23/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Questions and Answers (28/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Questions and Answers (5/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Referencing Approved Drug Products in ANDA Submissions (9/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Stability Case Studies (20/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
The Importance of Quality in Our Medicines (2/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Tips on Using the CDER NextGen Collaboration Portal (12/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Types of Fees and Q&A (24/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
Update on Technical Rejection Criteria for Study Data (14/28) Generic Drug Forum	Conference/Workshop	4/3/2019	Generic Drug Development; Drug Quality	No
A New Era for Homeopathic Drug Product Regulation	SBIA Chronicles Podcast	3/22/2019	New Drug Development	No
Framework for FDA’s Real-World Evidence Program	Webinar	3/15/2019	New Drug Development; Real World Evidence	No
Human Drug Establishment Registration and Drug Listing Compliance; CDERLearn Course 1 Certificates of completion and embedded videos are no longer available.	CDERLearn Course	3/12/2019	Registration and Listing	No
FDA Modernizes Clinical Trials with Master Protocols	SBIA Chronicles	2/26/2019	New Drug Development; IND; Clinical Trials and Research	No
FDA Modernizes Clinical Trials with Master Protocols	SBIA Chronicles Podcast	2/26/2019	New Drug Development; IND; Clinical Trials and Research	No
Final Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations	Webinar	12/6/2018	Clinical Trials and Research; Regulatory Submissions	No
Early Engagement with FDA to Discuss Novel Surrogate Endpoints	SBIA Chronicles	11/27/2018	New Drug Development; FDA Meetings/Communications	No
Early Engagement with FDA to Discuss Novel Surrogate Endpoints	SBIA Chronicles Podcast	11/27/2018	New Drug Development; FDA Meetings/Communications	No
FDA Study Data Technical Conformance Guide	Webinar	11/27/2018	Regulatory Submissions	No
Clinical Investigator Training Course (CITC) 2018: November 13 - 15, 2018	Conference/Workshop	11/13/2018	New Drug Development; Clinical Trials	No
FDA Facilitates the Use of Surrogate Endpoints in Drug Development	SBIA Chronicles	11/5/2018	Clinical Trials and Research; IND	No
FDA Facilitates the Use of Surrogate Endpoints in Drug Development	SBIA Chronicles Podcast	11/5/2018	Clinical Trials and Research; IND	No
A Case Example of the Review of Audit Trails in GCP Inspections (11/11) GCP Data Integrity Workshop	Conference/Workshop	10/23/2018	Clinical Trials and Research	No
Blinding of Bioequivalence Trials (9/11) GCP Data Integrity	Conference/Workshop	10/23/2018	Clinical Trials and Research	No
Data Integrity from International Perspectives (2/11) GCP Data Integrity Workshop	Conference/Workshop	10/23/2018	Clinical Trials and Research	No
Data Quality: Why Do We Care? (1/11) GCP Data Integrity	Conference/Workshop	10/23/2018	Clinical Trials and Research	No
Effective Use of Audit Trails (10/11) GCP Data Integrity Workshop	Conference/Workshop	10/23/2018	Clinical Trials and Research	No
FDA & MHRA Good Clinical Practice Workshop: Data Integrity in Global Clinical Trials - Are We There Yet?: October 23-24, 2018	Conference/Workshop	10/23/2018	New Drug Development; Clinical Trials and Research	No
Good Clinical Practice Assessment of Data Reliability in Registration Trials (5/11) GCP Data	Conference/Workshop	10/23/2018	Clinical Trials and Research	No
Overview of Data Integrity (4/11) GCP Data Integrity Workshop	Conference/Workshop	10/23/2018	Clinical Trials and Research	No
Quality and Control of Clinical Trial Data (6/11) GCP Data Integrity Workshop	Conference/Workshop	10/23/2018	Clinical Trials and Research	No
Quality Management Systems and Quality By Design (3/11) GCP Data Integrity Workshop	Conference/Workshop	10/23/2018	Clinical Trials and Research	No
The Data Management Plan – Pulling It All Together (7/11) GCP Data Integrity Workshop	Conference/Workshop	10/23/2018	Clinical Trials and Research	No
Unblinding – Let Me Count the Ways… (8/11) GCP Data Integrity	Conference/Workshop	10/23/2018	Clinical Trials and Research	No
Electronic Drug Registration and Listing Using CDER Direct: October 2, 2018	Conference/Workshop	10/2/2018	Registration and Listing	No
Writing the “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance	Webinar	9/27/2018	Labeling	No
Real-Time Review of Drug Applications is Now a Reality	SBIA Chronicles	9/20/2018	IND; NDA	No
Real-Time Review of Drug Applications is Now a Reality	SBIA Chronicles Podcast	9/20/2018	IND; NDA	No
Complex Generic Drug Product Development Workshop	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
Common Issues in Complex Drug Substance Review (8of39) Complex Generics 2018	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
Considerations for Establishing Q1/Q2 Sameness of Complex Formulations (10/39) Complex Generics '18	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
Considerations in Demonstrating Complex API Sameness (7/39) Complex Generics 2018	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
Equivalence testing of complex particle size distribution profiles-earth mover’s distance (15/39)	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
Establishing Appropriate BE Limits for Complex Formulations (14/39) Complex Generics 2018	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
In vitro bioequivalence testing for topical ophthalmic suspension products (17/39) Complex Generics	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
In Vitro Release Testing of Complex Formulations (11/39) Complex Generics 2018	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
Iron Colloid Drug Products: Characterization and Impurity (13/39) Complex Generics 2018	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
Multivesicular Liposomes: Physicochemical characterization & in vitro drug release testing (12/39)	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
Office of Generic Drugs Keynote (1/39) Complex Generics 2018	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
PBPK modeling and simulation used in assessing BE for generic ophthalmic products (19/39)	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
Peptide Drug Challenges through Pre-ANDA Processes & Case Studies (6/39) Complex Generics 2018	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
Pre-ANDA Logistics and Best Practices (3/39) Complex Generics 2018	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
Pre-ANDA Program Overview (2/39) Complex Generics 2018	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
Pre-ANDA review: Office of Pharmaceutical Quality (OPQ) (4/39) Complex Generics 2018	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
Product Quality Testing for Topical Ophthalmic Suspension Products (18/39) Complex Generics 2018	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
Questions and Panel Discussion (16/39) Complex Generics 2018	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
Questions and Panel Discussion (20/39) Complex Generics 2018	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
Questions and Panel Discussion (5/39) Complex Generics 2018	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
Questions and Panel Discussion (9/39) Complex Generics 2018	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
Complex Generic Drug Product Development Workshop - September 12-13, 2018	Conference/Workshop	9/12/2018	Generic Drug Development; Drug Quality	No
The FAERS Public Dashboard and its Value to the Pharmaceutical Industry	SBIA Chronicles	7/10/2018	Safety	No
The FAERS Public Dashboard and its Value to the Pharmaceutical Industry	SBIA Chronicles Podcast	7/10/2018	Safety	No
Postmarketing Drug Safety and Inspection Readiness - June 19, 2018 Deeper Dive Webinar	Webinar	6/19/2018	Inspections; Safety; Postapproval	No
BIMO, REMS, and PADE Inspection Readiness (3/3)	Webinar	6/19/2018	Safety; Inspections; Postapproval	No
Postmarketing Adverse Drug Experience (PADE) Inspections – (1/3)	Webinar	6/19/2018	Safety; Inspections; Postapproval	No
Risk Evaluation and Mitigation Strategies (REMS) Inspections (2/3)	Webinar	6/19/2018	Safety; Inspections; Postapproval	No
Benefit-Risk Considerations During Drug Product Development (8/14) REdI 2018	Conference/Workshop	5/18/2018	Drug Development; IND; NDA	No
CDER Small Business and Industry Assistance Overview (12/14) REdI 2018	Conference/Workshop	5/18/2018	Drug Development; IND; NDA; Resources	No
Chemistry, Manufacturing, and Controls (CMC) for an IND (7/14) REdI 2018	Conference/Workshop	5/18/2018	Drug Development; IND; NDA	No
Demystifying the Investigational New Drug (IND) Application for Drugs and Biologics (3/14) REdI 2018	Conference/Workshop	5/18/2018	Drug Development; IND; NDA	No
FDA Regulatory Requirements for Clinical Investigators and Case Examples (9/14) REdI 2018	Conference/Workshop	5/18/2018	Drug Development; IND; NDA	No
Formal Meetings for PDUFA Products and Communication Best Practices (4/14) REdI 2018	Conference/Workshop	5/18/2018	Drug Development; IND; NDA	No
Good Manufacturing Practices (GMPs) from an IND Perspective (11/14) REdI 2018	Conference/Workshop	5/18/2018	Drug Development; IND; NDA	No
Human Factors Engineering in Medical Products Reviews (2/14) REdI 2018	Conference/Workshop	5/18/2018	Drug Development; IND; NDA	No
Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5/14) REdI 2018	Conference/Workshop	5/18/2018	Drug Development; IND; NDA	No
Investigational New Drug Safety Reporting Requirements (10/14) REdI 2018	Conference/Workshop	5/18/2018	Drug Development; IND; NDA	No
Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6/14) REdI 2018	Conference/Workshop	5/18/2018	Drug Development; IND; NDA	No
Office of Regulatory Affairs Update (1/14) REdI 2018	Conference/Workshop	5/18/2018	Drug Development; IND; NDA	No
Panel Discussion (27/27) Generic Drugs Forum April 11-12, 2018	Conference/Workshop	5/18/2018	Drug Development; IND; NDA	No
The Active IND and Available Development Programs (13/14) REdI 2018	Conference/Workshop	5/18/2018	Drug Development; IND; NDA	No
Walkthrough of a Pre-Approval Manufacturing Site Inspection (14/14) REdI 2018	Conference/Workshop	5/18/2018	Drug Development; IND; NDA	No
Regulatory Education for Industry (REdI) Spring Conference:  May 15-16, 2018	Conference/Workshop	5/15/2018	New Drug Development; IND	No
Optimizing Your Data Submissions to FDA: Office of Vaccines Research and Review (OVRR) Data Submission	Webinar	5/8/2018	Regulatory Submissions	No
Updates to Forms 356h & 1571: Commercial vs. Research Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) Combination Products	Webinar	5/4/2018	Regulatory Submissions	No
ANDA Performance/Operations Update (3/27) Generic Drugs Forum April 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Application Communications: RBPM Communication with Industry throughout the IQA (24/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Best Practices for Conducting Bioequivalence Studies (16/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Bioequivalence Site and Manufacturing Facility Information in Applications (17/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Challenges in Generic Drug Safety and Surveillance (6/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Determining Whether to Submit an ANDA or a 505(b)(2) Application (12/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Drug Substance Quality Assessment: Best Practices (23/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Electronic Submissions (7/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Regulatory Submissions	No
Filing Review Basics – Examples of Refuse-to-Receive (RTR) (15/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
GDUFA II – Review Timelines (14/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
GDUFA II Pre-ANDA Program Meetings: Advice for Success (10/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality; FDA Meetings/Communications	No
GDUFA II User Fees: Update on Year One (21/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Generic Drug Product Quality Assessment (22/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Generic Drugs Forum: April 11 -12, 2018	Conference/Workshop	4/11/2018	Generic Drug Development	No
Good ANDA Submission and Assessment Practices and Software Support (5/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Integrated Process and Facilities Assessment (26/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Integrated Quality Assessment Process (19/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Keynote Address by Dr. Uhl (1/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Laboratory Science to Support Risk-Based Quality Assessments (25/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Microbiology Quality Assessment (18/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Office of Pharmaceutical Quality (OPQ) Policy Update (4/27) Generic Drugs Forum April 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Orange Book: 101 An Overview (11/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Panel Discussion (13/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Panel Discussion (20/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Panel Discussion (9/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Pharmaceutical Quality Update by Dr. Michael Kopcha (2/27) Generic Drugs Forum April 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
Using the ePortal to Submit a pre-ANDA Meeting (8/27) Generic Drugs Forum 2018	Conference/Workshop	4/11/2018	Generic Drug Development; Drug Quality	No
A New Era for Homeopathic Drug Product Regulation	SBIA Chronicles	3/22/2018	New Drug Development	No
A New Era for Homeopathic Drug Product Regulation	SBIA Chronicles Podcast	3/22/2018	New Drug Development	No
FDA Helping the Generic Industry Submit Complete Applications	SBIA Chronicles	2/6/2018	Generic Drug Development; Regulatory Submissions	No
FDA Helping the Generic Industry Submit Complete Applications	SBIA Chronicles Podcast	2/6/2018	Generic Drug Development; Regulatory Submissions	No
Draft guidance for Industry: Information Requests and Discipline Review Letters Under GDUFA	Webinar	12/18/2017	Generic Drug Development; Regulatory Submissions	No
REMS Integration Initiative: An Overview	Webinar	12/4/2017	Safety	No
PDUFA VI - A Time for Change	SBIA Chronicles	11/28/2017	User Fees; NDA	No
PDUFA VI - A Time for Change	SBIA Chronicles Podcast	11/28/2017	User Fees; NDA	No
Optimizing Your Study Data Submissions to FDA –Study Data Technical Conformance Guide October 2017 Version Update	Webinar	11/8/2017	Regulatory Submissions	No
Prescription Drug Labeling Conference 2017	Conference/Workshop	11/2/2017	Labeling	No
Draft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development	Webinar	11/2/2017	Generic Drug Development	No
PLR Implementation, CDER Staff for Labeling Review, and Resources (1/9) Prescription Drug Labeling 2017	Conference/Workshop	11/2/2017	Labeling	No
Consistency, Optimizing Communication, and Best Labeling Practices (2/9) Prescription Drug Labeling 2017	Conference/Workshop	11/2/2017	Labeling	No
Considerations for Developing the Indications and Usage Section of Labeling (3/9) Labeling 2017	Conference/Workshop	11/2/2017	Labeling	No
Converting Labeling for Older Drugs from the Old Format to the PLR Format (4/9) Prescription Drug Labeling 2017	Conference/Workshop	11/2/2017	Labeling	No
Novel and Adaptive Labeling Approaches: PLR and Beyond (5/9) Labeling 2017	Conference/Workshop	11/2/2017	Labeling	No
Cracking the Code for Clinical Pharmacology-Related Prescription Drug Labeling (6/9) Prescription Drug Labeling 2017	Conference/Workshop	11/2/2017	Labeling	No
Overview of SPL and Challenges with Medication Guide Extraction and Data Mining (7/9)Prescription Drug Labeling 2017	Conference/Workshop	11/2/2017	Labeling	No
Lessons Learned with the Pregnancy and Lactation Labeling Rule (PLLR) (8/9) Prescription Drug Labeling 2017	Conference/Workshop	11/2/2017	Labeling	No
Safety Considerations for Patient Instructions to Minimize Medication Errors (9/9) Labeling 2017	Conference/Workshop	11/2/2017	Labeling	No
Draft Guidance for Industry: Post-Complete Response Letter Meetings Between FDA and ANDA Applicants Under GDUFA	Webinar	11/1/2017	Generic Drug Development; FDA Meetings/Communications	No
Draft Guidance for Industry: Determining Whether to Submit an ANDA or 505(b)(2) Application	Webinar	10/13/2017	Generic Drug Development; NDA	No
Electronic Drug Registration & Listing Using CDER Direct: Extended Webinar	Webinar	10/5/2017	Registration and Listing	No
Draft Guidance for Industry: Formal Meetings Between FDA and ANDA Applicants of Complex Products Under GDUFA	Webinar	10/2/2017	Generic Drug Development; FDA Meetings/Communications	No
Regulatory Education for Industry (REdI): Fall Conference: September 27-28, 2017	Conference/Workshop	9/27/2017	New Drug Development; IND	No
Keynote (1/14) REdI 2017	Conference/Workshop	9/27/2017	New Drug Development; IND	No
Plenary: Regulatory Research at FDA (2/14) REdI 2017	Conference/Workshop	9/27/2017	New Drug Development; IND	No
Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017	Conference/Workshop	9/27/2017	New Drug Development; IND	No
FDA Communication During Drug Development (4/14) REdI 2017	Conference/Workshop	9/27/2017	New Drug Development; IND; FDA Meetings/Communications	No
Regulatory and Administrative Components of an IND Application (5/14) REdI 2017	Conference/Workshop	9/27/2017	New Drug Development; IND; Regulatory Submissions	No
Benefit-Risk Considerations in Drug Development (6/14) REdI 2017	Conference/Workshop	9/27/2017	New Drug Development; IND	No
Chemistry, Manufacturing Controls (CMC) in an Investigational New Drug (IND) (7/14) REdI 2017	Conference/Workshop	9/27/2017	New Drug Development; IND; Drug Quality	No
Overview of Non-clinical Assessment in Drug Development (8/14) REdI 2017	Conference/Workshop	9/27/2017	New Drug Development; IND	No
Submit Your Investigational New Drug (IND) Application and Clinical Holds (9/14) REdI 2017	Conference/Workshop	9/27/2017	New Drug Development; IND; Regulatory Submissions	No
Additional Sponsor Responsibilities (10/14) REdI 2017	Conference/Workshop	9/27/2017	New Drug Development; IND	No
Overview of Clinical Investigator Responsibilities and Inspectional Findings (11/14) REdI 2017	Conference/Workshop	9/27/2017	New Drug Development; IND	No
Walkthrough of an FDA Clinical Investigator Site Inspection (12/14) REdI 2017	Conference/Workshop	9/27/2017	New Drug Development; IND; Inspections	No
Overview of FDA's Expanded Access Program (13/14) REdI 2017	Conference/Workshop	9/27/2017	New Drug Development; IND	No
Live Demo of the FDA Adverse Events Reporting System (14/14) REdI 2017	Conference/Workshop	9/27/2017	New Drug Development; IND; Drug Safety	No
Real-World Data and Evidence in Drug Development	SBIA Chronicles	8/24/2017	New Drug Development	No
Electronic Common Technical Document (eCTD): CDERLearn Course 1 Certificates of completion and embedded videos are no longer available.	CDERLearn Course	8/3/2017	Regulatory Submissions	No
Optimizing Your Study Data Submissions to FDA – Updates from CDER and CBER	Webinar	7/13/2017	Regulatory Submissions	No
Updates to the Study Data Technical Conformance Guide (1/4) Technical Conformance	Webinar	7/13/2017	Regulatory Submissions	No
Providing Clinical Study Data to the Office of Vaccines (2/4) Tech Conformance	Webinar	7/13/2017	Regulatory Submissions	No
Biologics Quality Bioresearch and Study Data Submissions (3/4) Technical Conformance	Webinar	7/13/2017	Regulatory Submissions	No
Panel Questions and Discussion (4/4) Study Data Technical Conformance Webinar	Webinar	7/13/2017	Regulatory Submissions	No
Draft Guidance for Industry: ANDA Submissions – Amendments to Abbreviated New Drug Applications Under GDUFA II II	Webinar	7/5/2017	Generic Drug Development; Regulatory Submissions	No
Presenting Clinical Pharmacology Information in Prescription Drug Labeling	Webinar	6/19/2017	Labeling	No
Risk Evaluation and Mitigation Strategies (REMS): A Deeper Dive	Webinar	6/15/2017	New Drug Development; Safety	No
REMS Purpose, Process, and Challenges (1/2) REMS Webinar	Webinar	6/15/2017	New Drug Development; Safety	No
Structured Product Labeling Format: An Introduction (2/2) REMS Webinar	Webinar	6/15/2017	New Drug Development; Safety; Regulatory Submissions	No
Submitting Master Files in eCTD Format: When and How to Comply	SBIA Chronicles	5/25/2017	Drug Master Files; Regulatory Submissions	No
Submitting Master Files in eCTD Format: When and How to Comply	SBIA Chronicles Podcast	5/25/2017	Drug Master Files; Regulatory Submissions	No
Regulatory Education for Industry (REdI): Spring Conference: May 9-10, 2017	Conference/Workshop	5/9/2017	New Drug Development; IND	No
The Complexities of Compounding	SBIA Chronicles	4/20/2017	Compounding	No
The Complexities of Compounding	SBIA Chronicles Podcast	4/20/2017	Compounding	No
Generic Drugs Forum: April 4-5, 2017	Conference/Workshop	4/4/2017	Generic Drug Development	No
Keynote – Office of Generic Drugs (1/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development	No
Keynote – Office of Pharmaceutical Quality (2/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development; Drug Quality	No
ANDA Performance/Operations Update (3/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development	No
Office of Pharmaceutical Quality Policy Update (4/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development; Drug Quality	No
GDUFA Regulatory Science Research Update (5/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development	No
Preparing for GDUFA II User Fees (6/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development	No
eCTD (7/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development; Regulatory Submissions	No
Panel Discussion (8/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development; Regulatory Submissions; Drug Quality	No
GDUFA II (9/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development; User Fees	No
Development of Single, Shared System REMS (10/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development; Drug Safety	No
Introduction to “The ANDA Review Pathway” (11/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development	No
ANDA Policy and Regulatory Considerations Prior to Filing (12/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development	No
Panel Discussion (13/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development	No
Filing Review – Do’s and Don’ts (14/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development; Regulatory Submissions	No
RPM Communications Associated with “Take Action” Process (15/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development	No
FDA’s Bioequivalence Recommendations for Generic Drugs (16/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development	No
Review of Clinical Endpoint Bioequivalence Studies in ANDAs (17/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development	No
Generic Labeling: Strategies for Providing High-quality Submissions (18/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development; Labeling	No
Panel Discussion (19/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development	No
OPQ Integrated Quality Assessment (IQA) Process (20/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development; Drug Quality	No
OPQ Communications with Industry (21/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development; Drug Quality	No
Drug Substance Review - ANDA (22/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development; Drug Quality	No
Generic Drug Product Quality Review (23/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development; Drug Quality	No
Dissolution Method Development for Generic Drugs (24/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development; Drug Quality	No
Manufacturing Process and Controls (25/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development; Drug Quality	No
Facility Evaluation and Inspection (26/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development; Drug Quality; Inspections	No
Product Quality Microbiology Assessment (27/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development; Drug Quality	No
Panel Discussion (28/28) Generic Drugs Forum 2017	Conference/Workshop	4/4/2017	Generic Drug Development; Drug Quality; Inspections	No
CDER Microbiology Issues: A Deeper Dive	Webinar	3/15/2017	Drug Quality	No
Microbiology Assessment: Recommendations for Nonsterile Products (1/6) Microbiology Webinar	Webinar	3/15/2017	Drug Quality	No
Case Study: Micro Investigation of Contamination by Burkholderia multivorans (2/6) Microbiology Webinar	Webinar	3/15/2017	Drug Quality	No
Panel Questions and Discussion (3/6) CDER Microbiology Webinar	Webinar	3/15/2017	Drug Quality	No
Building a Better Sterility Assurance Application (4/6) CDER Microbiology Webinar	Webinar	3/15/2017	Drug Quality	No
Aseptic Processing of Biological Products: Regulatory Issues (5/6) Microbiology Webinar	Webinar	3/15/2017	Drug Quality	No
Panel Questions and Discussion (6/6) CDER Microbiology Webinar	Webinar	3/15/2017	Drug Quality	No
Draft Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions	Webinar	3/6/2017	Generic Drug Development	No
Best Practices for Communication Between FDA and IND Sponsors During Drug Development: CDERLearn Course 1   Certificates of completion and embedded videos are no longer available.	CDERLearn Course	2/1/2017	FDA Meetings/Communications; IND	No
FDA Addresses Small Business Concerns in GDUFA II	SBIA Chronicles	1/26/2017	Generic Drug Development	No
FDA Addresses Small Business Concerns in GDUFA II	SBIA Chronicles Podcast	1/26/2017	Generic Drug Development	No
FDA's Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond: CDERLearn Course 1   Certificates of completion and embedded videos are no longer available.	CDERLearn Course	6/7/2021	New Drug Development; Safety; Quality	No
GDUFA Self-Identification (SPL) Submission – Part 1: CDERLearn Course 1   Certificates of completion and embedded videos are no longer available.	CDERLearn Course	1/12/2016	Generic Drug Development; Regulatory Submissions	No
GDUFA Self-Identification (SPL) Submission – Part 2: CDERLearn Course 1 Certificates of completion and embedded videos are no longer available.	CDERLearn Course	1/12/2016	Generic Drug Development; Regulatory Submissions	No
Overview of the Generic Drug User Fee Amendments of 2012 (GDUFA): CDERLearn Course 1   Certificates of completion and embedded videos are no longer available.	CDERLearn Course	1/12/2016	Generic Drug Development; User Fees	No
Case Studies in FDA's Drug Regulatory Processes: CDERLearn Course 1   Certificates of completion and embedded videos are no longer available.	CDERLearn Course	10/22/2015	New Drug Development; NDA; IND	No
Engaging with the FDA During New Drug Development 1   Certificates of completion and embedded videos are no longer available.	CDERLearn Course	9/26/2014	New Drug Development; FDA Meetings/Communications	No
Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND: CDERLearn Course 1   Certificates of completion and embedded videos are no longer available.	CDERLearn Course	9/17/2014	New Drug Development; Drug Quality	No
CDER Presentations Library	Webinar		New Drug Development; Generic Drug Development; Biosimilars; Clinical Trials and Research	No
CDER Webinars	Webinar		New Drug Development; Generic Drug Development; Biosimilars; Clinical Trials and Research	No
Guidance Webinar Series	Webinar		New Drug Development; Generic Drug Development; Biosimilars; Clinical Trials and Research	No

Program Overview

 

• 1 a b c d e f g h i j Certificates of completion and embedded videos are no longer available. To access video content within the courses, click on the capital letter D below where a video occurs to see text version of video content.