CDER Small Business and Industry Assistance (SBIA) Learn
Online Training Repository
The table below lists SBIA multimedia training resources, including conference/webinar presentations and recordings, online courses, newsletters and podcasts. Explore the SBIA On-Demand Learning Library 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.
Use filters and search box to find resources
Advanced search (combine topic and search terms)
| Summary | Type | Issued/Updated | Topic | Subtítulos en Español |
|---|---|---|---|---|
| Quality and Regulatory Predictability: Shaping USP Standards | Webinar | 12/11/2025 | Drug Development, Drug Quality, Manufacturing, USP Standards, | No |
| FDA Electronic Drug Registration and Listing (eDRLS) using CDER Direct Training Modules | On Demand | 7/24/2025 | Import/Export, International, Registration and Listing | No |
| FDA Pharmaceutical Quality Training Modules | On Demand | 7/24/2025 | Drug Quality, Quality Assessments, Supply Chain, Manufacturing, Emerging Technology, Generic Drug Development | No |
| FDA Clinical Trials Training Modules | On Demand | 7/24/2025 | Chemistry Manufacturing and Controls (CMC), Clinical Trials and Research, Digital Health Technologies, Drug Safety, Good Clinical Practice, IND, Inspections, International, New Drug Development, Real World Evidence | No |
| FDA Advancing Generic Drug Development Training Modules | On Demand | 7/24/2025 | ANDA, Complex Generic Drug, Product Specific Guidances, Generic Drug Development, Regulatory Assessment, Biomarkers, Bioequivalence, Topical Products, Orally Inhaled Products, Complex Injectables | No |
| OTC Monograph Drug User Fee Program (OMUFA): Understanding FY 2025 User Fees and Registration | Webinar | 5/20/2025 | OTC Drug Regulation, User Fees | No |
| FDA CDER Overview: Certificates of Confidentiality | On Demand | 5/07/2025 | BLA, Clinical Trials and Research, Devices, Drug Development, NDA, New Drug Development | No |
| CDER Bioresearch Monitoring: Electronic Submission Requirements for New Drug and Biologic Licensing Applications | On Demand | 5/06/2025 | BIMO, BLA, Electronic Submissions, New Drug Development, Inspections | No |
| Navigating Controlled Correspondences to Support Generic Drug Development | Webinar | 2/27/2025 | ANDA, Controlled Correspondence, Generic Drug Development, Regulatory Submissions | No |
| Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions | Webinar | 3/13/2025 | ANDA, Drug Master Files, Generic Drug Development, Model Master Files, Regulatory Submissions | No |
| Improving Data Quality with Centralized Statistical Monitoring with Dr. Paul Schuette and Xiaofeng (Tina) Wang | SBIA Chronicles Podcast | 12/13/2024 | Statistical Analysis | No |
| Generic Drugs Forum (GDF) 2025 | Conference | 4/9/2025 | ANDA, Bioequivalence, Generic Drug Development | No |
| BsUFA III Regulatory Science Pilot Program: Progress Update | Webinar | 1/22/2025 | BLA; Biologics; Biosimilars; International; Regulatory Science | No |
| FDA Clinical Investigator Training Course (CITC) 2024 | Conference | 12/10/2024 | Chemistry Manufacturing and Controls (CMC), Clinical Trials and Research, Digital Health Technologies, Drug Safety, Good Clinical Practice, IND, Inspections, International, New Drug Development, Real World Evidence | No |
| Clinical Pharmacology Considerations for Novel Therapeutic Modalities | Webinar | 12/4/2024 | Antibody Drug Conjugates, Clinical Pharmacology, Clinical Trials and Research, Drug Safety, IND, International, New Drug Development, Oligonucleotide Therapeutics | No |
| M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms -- Implementing the Final Guidance | Webinar | 11/21/2024 | ANDA, Bioequivalence, Generic Drug Development, International | No |
| The Need for Artificial Intelligence in Pharmacovigilance with Dr. Robert Ball | SBIA Chronicles Podcast | 11/14/2024 | Artificial Intelligence | 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 |
| 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 |
| 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 |
| Draft guidance for Industry: Information Requests and Discipline Review Letters Under GDUFA | Webinar | 12/18/2017 | Generic Drug Development; Regulatory Submissions | No |
| Draft Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions | Webinar | 3/6/2017 | Generic Drug Development | No |
Program Overview