U.S. flag An official website of the United States government
  1. Home
  2. Drugs
  3. Development & Approval Process | Drugs
  4. CDER Small Business & Industry Assistance (SBIA)
  5. CDER Small Business and Industry Assistance (SBIA) Learn
  1. CDER Small Business & Industry Assistance (SBIA)

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 recordings on YouTube to browse by most popular videos and see upcoming events for a list of future live events.

Use filters and search box to find resources

Advanced search (combine topic and search terms)

Summary Type Issued/Updated Topic
Pharmaceutical Quality Symposium 2021: Innovations in a Changing World Symposium 10/26/2021 Registration and Listing
Electronic Drug Registration and Listing (eDRLS) Using CDER Direct Conference/Workshop 10/13/2021 Registration and Listing
Webinar 10/5/2021 DSCSA

Advancing Generic Drug Development: Translating Science to Approval

Conference/Workshop 9/21/2021 New Drug Development
The ABCs of Product Specific Guidances CDER SBIA Chronicles 9/2/2021 Generic Drug Development
The ABCs of Product Specific Guidances CDER SBIA Chronicles Podcast 9/2/2021 Generic Drug Development
Promotional Submissions in eCTD Format – Grouped Submissions Webinar 8/31/2021 Regulatory Submissions
Manufacturing, Supply Chain, and Inspections during the COVID19 Public Health Emergency Webinar 8/25/2021 Inspections; Drug Quality; DSCSA

Regulatory Education for Industry (REdI) Annual Conference 2021

Conference/Workshop 7/19/2021 New Drug Development
2021 REdI Conference Keynote Address by Janet Woodcock, MD Conference/Workshop 7/19/2021 New Drug Development
2021 REdI Conference Plenary Session with Patrizia Cavazzoni, MD Conference/Workshop 7/19/2021 New Drug Development
OND Reorganization and the New Drugs Regulatory Program Modernization Conference/Workshop 7/19/2021 New Drug Development
ANDA Efforts Related to COVID-19 Conference/Workshop 7/19/2021 Generic Drug Development
Resource Capacity Planning: How CDER is Modernizing Resource Planning Capabilities Conference/Workshop 7/19/2021 New Drug Development
CDER NextGen Portal Conference/Workshop 7/19/2021 Regulatory Submissions
Electronic Common Technical Document (eCTD) Conference/Workshop 7/19/2021 Regulatory Submissions
Product Quality Consideration for Emergency Use Authorizations (EUAs) Conference/Workshop 7/19/2021 New Drug Development
Strategies to Address Potential Medication Errors for EUA Products for COVID-19 Conference/Workshop 7/19/2021 New Drug Development; Safety
Clinical Pharmacology Regulatory Sciences in Drug Development and Precision Medicine Conference/Workshop 7/19/2021 New Drug Development
CDER’s Role in Public Health Emergency Response and Medical Countermeasure Development  Conference/Workshop 7/19/2021 New Drug Development
Where Do We Go from Here? How the Ombudsman Can Help Conference/Workshop 7/19/2021 FDA Meetings/Communications
Communication Best Practices – Interacting with Regulatory Project Managers in CDER/ORO Conference/Workshop 7/19/2021 FDA Meetings/Communications
Communications in a Global Pandemic Conference/Workshop 7/19/2021 FDA Meetings/Communications
Regulatory Policy: Role in Guiding Decision Making in CDER Conference/Workshop 7/19/2021 New Drug Development
Role of the Product Jurisdiction Team in the Medical Product Development Process Conference/Workshop 7/19/2021 New Drug Development
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
OSI’s Role in the Drug Development Process and Impact of COVID-19 Conference/Workshop 7/19/2021 New Drug Development

Identification of Medicinal Products: Path to Global Implementation

Webinar 6/11/2021 International, Labeling, Regulatory Submissions
Webinar 6/3/2021

OTC Drug Regulation

FDA Study Data Technical Rejection Criteria (TRC): What you need to know! Webinar 5/21/2021 Regulatory Submissions 
FY 2021 Generic Drug Science and Research Initiatives Public Workshop Conference/Workshop 6/23/2021 Generic Drug Development
Welcome, Keynote, and Industry Survey Results - GDUFA Science and Research Initiatives Public Workshop Conference/Workshop 6/23/2021 Generic Drug Development
Generic Industry Challenge Perspectives - GDUFA Science and Research Initiatives Public Workshop Conference/Workshop 6/23/2021 Generic Drug Development
Public Comment - GDUFA Science and Research Initiatives Public Workshop Conference/Workshop 6/23/2021 Generic Drug Development
Panel Discussion with Generic Industry - GDUFA Science and Research Initiatives Public Workshop Conference/Workshop 6/23/2021 Generic Drug Development
Model-Integrated Evidence for Generic Drug Development – Session 1A Conference/Workshop 6/23/2021 Generic Drug Development
Model-Integrated Evidence for Generic Drug Development – Session 1B Conference/Workshop 6/23/2021 Generic Drug Development
Model-Integrated Evidence for Generic Drug Development – Session 1C Conference/Workshop 6/23/2021 Generic Drug Development
Complex Product Characterization/Analysis - Session 2A Conference/Workshop 6/23/2021 Generic Drug Development
Complex Product Characterization/Analysis - Session 2B Conference/Workshop 6/23/2021 Generic Drug Development
Complex Product Characterization/Analysis - Session 2C Conference/Workshop 6/23/2021 Generic Drug Development
In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3A Conference/Workshop 6/23/2021 Generic Drug Development
In Vitro and In Vivo BE Approaches: Challenges and Opportunities – Session 3B Conference/Workshop 6/23/2021 Generic Drug Development
Closing Remarks - Robert Lioberger, PhD, Director, Office of Research and Standards (ORS), OGD, FDA Conference/Workshop 6/23/2021 Generic Drug Development
FDA and Health Canada Regional ICH Consultation Conference/Workshop 5/14/2021 Clinical Trials and Research; International; New Drug Development
FDA and Health Canada Regional ICH Consultation - Part I Conference/Workshop 5/14/2021 Clinical Trials and Research; International; New Drug Development
FDA and Health Canada Regional ICH Consultation - Part II Conference/Workshop 5/14/2021 Clinical Trials and Research; International; New Drug Development
Common Labeling Deficiencies and Tips for Generic Drug Applications Webinar 5/7/2021 Generic Drug Development; Labeling
FDA Product-Specific Guidances: Lighting the Development Pathway for Generic Drugs Webinar 5/5/2021 Generic Drug Development; New Drug Development; Orange Book
Generic Drugs Forum 2021: Lifecycle of a Generic Drug Conference/Workshop 4/28/2021 Generic Drug Development
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
Office of Pharmaceutical Quality (OPQ) Update Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality
Global Generic Drug Landscape Conference/Workshop 4/28/2021 Generic Drug Development
Data Integrity Issues in Bioequivalence Studies Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality
Bioavailability/Bioequivalence Site Evaluation During the Pandemic Conference/Workshop 4/28/2021 Generic Drug Development
Impact of Data Integrity Issues on Pharmacology/Toxicology Studies in ANDAs Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality
Generic Drugs Forum 2021: Panel Discussion 1 Conference/Workshop 4/28/2021 Generic Drug Development
OPQ Policy Update Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality
Update on CDER’s Quality Management Maturity Program Conference/Workshop 4/28/2021 Generic Drug Development
Generic Drugs Forum 2021: Panel Discussion 2 Conference/Workshop 4/28/2021 Generic Drug Development
Pre-ANDA Program Conference/Workshop 4/28/2021 Generic Drug Development; FDA Meetings/Communications
Pre-ANDA Program Update and Tips for Success – OPQ Perspective Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality
Controlled Correspondence Related to Pharmaceutical Quality Conference/Workshop 4/28/2021 Generic Drug Development; FDA Meetings/Communications
Generic Drugs Forum 2021: Panel Discussion 3 Conference/Workshop 4/28/2021 Generic Drug Development
Division of Filing Review: Helpful Tips for Submission of an ANDA or Controlled Correspondence Conference/Workshop 4/28/2021 Generic Drug Development
>ANDA Labeling: Recommendations and Helpful Resources Conference/Workshop 4/28/2021 Generic Drug Development; Labeling
Generic Drugs Forum 2021: Panel Discussion 4 Conference/Workshop 4/28/2021 Generic Drug Development
Addressing Common Challenges in BE Studies Due to COVID-19: OGD’s Approach Conference/Workshop 4/28/2021 Generic Drug Development
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
Generic Drugs Forum 2021: Panel Discussion 5 Conference/Workshop 4/28/2021 Generic Drug Development
Mid-Review Cycle Meeting Overview Conference/Workshop 4/28/2021 Generic Drug Development; FDA Meetings/Communications
Information to Include with Cover Letters Conference/Workshop 4/28/2021 Generic Drug Development; FDA Meetings/Communications
Application Communications – Quality Assessment Perspective Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality
Generic Drugs Forum 2021: Panel Discussion 6 Conference/Workshop 4/28/2021 Generic Drug Development
Fostering Innovation Through OPQ’s Emerging Technology Program Conference/Workshop 4/28/2021 Generic Drug Development
Lab Science to Support Generic Complex Drug Product Assessment Conference/Workshop 4/28/2021 Generic Drug Development
Assessment of Extractables/Leachables Data in ANDA Submissions Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality
Generic Drugs Forum 2021: Panel Discussion 7 Conference/Workshop 4/28/2021 Generic Drug Development
Biopharmaceutics Risk Assessment to Guide Dissolution Method Development for Solid Oral Dosage Forms Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality
Integrated Manufacturing Assessment: Expectations Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality
Building a Better Sterility Assurance Application Conference/Workshop 4/28/2021 Generic Drug Development; Drug Quality
Generic Drugs Forum 2021: Panel Discussion 8 Conference/Workshop 4/28/2021 Generic Drug Development
Postmarketing Safety and Surveillance of Generic Drugs Update Conference/Workshop 4/28/2021 Generic Drug Development
Premarket Review of Expedited Serious Adverse Event Reports of BA/BE Studies Conference/Workshop 4/28/2021 Generic Drug Development; Safety
Update on Shared System REMS for Generic Drug Conference/Workshop 4/28/2021 Generic Drug Development; Safety
ANDA Postapproval Changes: Best Practices and Strategies to Avoid Common Quality Assessment Issues Conference/Workshop 4/28/2021 Generic Drug Development
Generic Drugs Forum 2021: Panel Discussion 9 Conference/Workshop 4/28/2021 Generic Drug Development
Drug Master File (DMF) and Drug Substance Question and Answer Webinar Following March 3-4, 2021 Workshop Webinar 4/9/2021 Drug Master Files
FDA Safety Report Type Flag Requirement for FAERS Submissions Webinar 2/19/2021 Regulatory Submissions; Safety
Oncology Therapy Development Workshop: Pivotal Steps and Avoiding Pitfalls for Start-ups Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research
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
Innovation Mindset – Advancing Science to Therapies Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research
FDA Oncology Drug Development Overview – Past to Present Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research
Federal Resources for Innovative Cancer Startups: More Than Just Funding Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research
Best Practices for Venture Capital Fundraising: Learn How Early-stage VCs Think Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research
Funding Sources Panel Discussion Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research
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
Assembling the Best Team to Navigate through Preclinical Development Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research
Consulting Companies and FDA Limitations Panel Discussion Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research
CMC Considerations for CAR T Cell Product Development Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research
CMC Considerations for Oncolytic Viral Product Development Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research
Preclinical Considerations for Cell and Gene Therapy Products, an FDA Perspective Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research
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
Oncology Therapy Development Workshop Overview, Day Two Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research
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
CMC Considerations for Biotechnology Product Development: A Regulatory Perspective Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research
Getting to First-in-Human for Small Molecules and Biologics Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research
Designing First-In-Human Trials for Small Molecules and Biologics Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research
Planning for Co-development of Companion Diagnostics Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research
Clinical Development of Radiopharmaceuticals a Theranostic Pairs and Dosimetry Considerations Conference/Workshop 3/30/2021 New Drug Development; Clinical Trials and Research
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
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
Drug Master File (DMF) and Drug Substance Workshop Webinar 3/3/2021 Drug Master Files
Regulatory Perspectives for Development of Drugs for Treatment of NASH Webinar 1/29/2021 New Drug Development; Clinical Trials and Research
OTC Monograph Reform in the CARES Act: Safety Orders Webinar 1/27/2021 OTC Drug Regulation
CDER Compliance Conference Conference/Workshop 1/14/2021 Compliance, Import/Export; Compounding; DSCSA; Safety
Compounding: Cleanrooms and Cleanroom Behaviors: Why they Matter Conference/Workshop 1/14/2021 Compliance, Import/Export; Compounding
Enhanced Drug Distribution Security – Drug Supply Chain Security Act (DSCSA) Implementation Updates Conference/Workshop 1/14/2021 Compliance, DSCSA
A Glance at Drug Importation Requirements Conference/Workshop 1/14/2021 Compliance, Import/Export; Compounding
Risk Evaluation and Mitigation Strategies (REMS) Compliance Program Conference/Workshop 1/14/2021 Compliance, Safety
Diversity in Clinical Trials: Learn about Enrollment Trends and Resources from FDA Webinar 12/16/2020 Clinical Trials and Research
SEND for CBER, What You Need to Know Webninar 12/4/2020 Regulatory Submissions
Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions Webinar 11/20/2020 Generic Drug Development
Office of Prescription Drug Promotion - Core Launch Review Process Webinar 11/20/2020 Marketing
Bridging the Gap – Promoting Safe and Effective Prescription Drug Use in Geriatric Patients Webinar 11/13/2020 Labeling
Office of New Drug (OND) Research: Seeking Collaborators, Funding Opportunities Available  Webinar 11/6/2020 New Drug Development
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
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
Orange Book 101: An Overview of FDA's Orange Book Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book
How to Update Orange Book Information Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book
How to Update Orange Book Information – Panel Discussion Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book
An Overview of FDA's Patent Listing Process Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book
Changes to Orange Book Patent Information Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book
Orange Book Patent Information – Panel Discussion Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book
The Patent Information Dispute Process Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book
Best Practices for 505(b)(2) and ANDA Applicants Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book
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
Orange Book Exclusivity: An Introduction and Overview Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book
Orange Book Exclusivity: Part I - NCE and 3-Year Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book
Orange Book Exclusivity – Panel Discussion Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book
Orange Book Exclusivity: Part II - Pediatric, Orphan, and GAIN Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book
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
Orange Book Exclusivity – Panel Discussion Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book
Orange Book: An Overview of Therapeutic Equivalence Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book
Referencing Approved Drug Products in ANDA Submissions Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book
Orange Book: Looking Towards the Future Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book
Closing Remarks Conference/Workshop 10/27/2020 Generic Drug Development; New Drug Development; Orange Book
New Approaches for an Integrated Nonclinical-Clinical QT/Proarrhythmic Risk Assessment Webinar 10/15/2020 Drug Development; Clinical Trials and Research
Drug Registration and Listing Workshop Conference/Workshop 10/8/2020 Registration and Listing
Drug Registration and Listing Workshop: Labeler Code Request Conference/Workshop 10/8/2020 Registration and Listing
Drug Registration and Listing Workshop: Establishment Registration Conference/Workshop 10/8/2020 Registration and Listing
Drug Registration and Listing Workshop: Drug Listing Conference/Workshop 10/8/2020 Registration and Listing
Drug Registration and Listing Workshop: 503B Compounder Product Reporting Using CDERDirect Conference/Workshop 10/8/2020 Registration and Listing
Drug Registration and Listing Workshop: Establishment Registration and Drug Listing Compliance Program Conference/Workshop 10/8/2020 Registration and Listing
Overview of the Guidance for Industry: Control of Nitrosamine Impurities in Human Drugs Webinar 10/2/2020 Drug Quality
Advancing Innovative Science in Generic Drug Development Workshop Conference/Workshop 9/29/2020 Generic Drug Development
Dr. Hahn's Remarks to “Advancing Innovative Science in Generic Drug Development” Workshop 9/29/2020 Conference/Workshop 9/29/2020 Generic Drug Development
Update on GDUFA Science and Research Conference/Workshop 9/29/2020 Generic Drug Development
March 2020 Transition Under the BPCI Act: Impact on Generics Conference/Workshop 9/29/2020 Generic Drug Development
Related Impurities Assessment Considerations for APIs in the Generic Complex Peptide Products Conference/Workshop 9/29/2020 Generic Drug Development
Non-clinical Evaluation of Immunogenicity Risk of Generic Complex Peptide Products Conference/Workshop 9/29/2020 Generic Drug Development
Panel Discussion on Method Development / Validations for Non-traditional Analytical Methods Conference/Workshop 9/29/2020 Generic Drug Development
Developing and Validating Advanced Microscopy Methods for Supporting Complex Product Equivalence Conference/Workshop 9/29/2020 Generic Drug Development
Developing & Validating Commonly Employed Particle Sizing Methods to Support BE and Product Quality  Conference/Workshop 9/29/2020 Generic Drug Development
Quantitative Methods for Determining Equivalence of Particle Size Distributions Conference/Workshop 9/29/2020 Generic Drug Development
Panel for Advanced Analytical and Statistical Methods for Assessing Particle Size Distributions Conference/Workshop 9/29/2020 Generic Drug Development
Assessment of Complex Drug Product – Physicochemical Characteristics to Support In Vitro BE Studies Conference/Workshop 9/29/2020 Generic Drug Development
In Vitro Release Testing for Complex Generics: A Bioequivalence Perspective Conference/Workshop 9/29/2020 Generic Drug Development
In Vitro Bioequivalence Studies of Topical Drug Products: Challenges and Promises of IVRT and IVPT Conference/Workshop 9/29/2020 Generic Drug Development
Panel on Development and Validation Considerations for Drug Release and Permeation Testing  Conference/Workshop 9/29/2020 Generic Drug Development
Formulation Assessments: General Q1/Q2 Inquiries to Supporting Complex Excipient Sameness Conference/Workshop 9/29/2020 Generic Drug Development
Calculating Maximum Daily Dose (MDD) for Orally Administered Drug Products Conference/Workshop 9/29/2020 Generic Drug Development
What’s New in the Inactive Ingredient Database (IID)? Conference/Workshop 9/29/2020 Generic Drug Development
Local Toxicity Considerations for Qualifying Excipients in Generic Drugs Conference/Workshop 9/29/2020 Generic Drug Development
Panel on Excipient and Formulation Considerations  Conference/Workshop 9/29/2020 Generic Drug Development
In Vitro Studies for Alternative BE Approaches to Comparative Clinical Endpoint BE Studies Conference/Workshop 9/29/2020 Generic Drug Development
The Potential of PK BE Studies in Detecting Regional Deposition with Orally Inhaled Drugs Conference/Workshop 9/29/2020 Generic Drug Development
Regional Deposition and Systemic Pharmacokinetic Data of OINDPs with Modeling and Simulation Conference/Workshop 9/29/2020 Generic Drug Development
Panel on Future Directions, Emerging Technology, and Current Thinking on Alternative BE Approaches  Conference/Workshop 9/29/2020 Generic Drug Development
Topical Dosage Forms: Emerging Insights and Implications for Bioequivalence Approaches Conference/Workshop 9/29/2020 Generic Drug Development
In Vivo Dermal Microperfusion & Microdialysis Bioequivalence Approaches Conference/Workshop 9/29/2020 Generic Drug Development
Non-Invasive Raman Spectroscopy-Based Bioequivalence Approaches Conference/Workshop 9/29/2020 Generic Drug Development
Panel on Topical Dermatologic Products  Conference/Workshop 9/29/2020 Generic Drug Development
PBPK to Guide Study Design and Product Development for Generic Dermatological Products Conference/Workshop 9/29/2020 Generic Drug Development
Model-Informed and Model-Integrated Approach in BE Assessment of Long-Acting Injectable Products Conference/Workshop 9/29/2020 Generic Drug Development
Panel on Emerging Use of Modeling and Simulation for Bioequivalence  Conference/Workshop 9/29/2020 Generic Drug Development
Biopharmaceutics Classification System Class 3 Waiver Conference/Workshop 9/29/2020 Generic Drug Development
Using PBPK Absorption Modeling to Support Biopharmaceutics Classification System Class 3 Drug Waiver Conference/Workshop 9/29/2020 Generic Drug Development
Alternatives to f2 Testing for Dissolution Similarity – f2 Bootstrapping and MSD Method Conference/Workshop 9/29/2020 Generic Drug Development
Panel on Practical Considerations in the Study Design and Data Evaluation Recommended in PSGs Conference/Workshop 9/29/2020 Generic Drug Development
A Closer Look into the Nasogastric and Gastric Feeding Tube Study Recommendations Conference/Workshop 9/29/2020 Generic Drug Development
In Vitro Enteral (Nasogastric and Gastric) Feeding Tube Testing of Generic Drugs: Case Studies Conference/Workshop 9/29/2020 Generic Drug Development
Practical Considerations for Bioequivalence of GI Locally-Acting Products Conference/Workshop 9/29/2020 Generic Drug Development
Panel on In Vitro Feeding Tube Testing and GI Locally-Acting Products Conference/Workshop 9/29/2020 Generic Drug Development
Cannabis Clinical Research: Drug Master Files (DMFs) & Quality Considerations Webinar 9/16/2020 Drug Master Files
Real-world Evidence for Drugs, Biologics, and Devices - REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; Real World Evidence; Postapproval
Restructure of the Office of New Drugs (OND) - REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval
So, Your NDA Was Approved – Now What?! Post-approval Responsibilities and Obligations- REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval
Overview of Postmarketing Drug Safety Reporting Requirements - REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Safety
Drug Shortages - REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Drug Shortages
Enhanced Drug Distribution Security – DSCSA Implementation Updates - REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; DSCSA
CDER Export Certificate Program - REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Import/Export
SBIA Program Overview - REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Resources
Post-Approval Submission of Promotional Materials to the OPDP - REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Marketing
Requirement for Electronic Submission of an Application and Study Data - REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Regulatory Submissions
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 
Lifecycle Changes to Chemistry, Manufacture, and Controls in NDAs - REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Drug Quality 
Post-approval Considerations for Changes to Manufacturing Process and Facilities - REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Drug Quality 
Questions and Panel Discussion – Post-approval CMC and Manufacturing - REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Drug Quality 
FDA Drug Manufacturing Inspections - REdI 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval; Inspections
Regulatory Education for Industry (REdI) Annual Conference - 2020 Conference/Workshop 8/25/2020 New Drug Development; NDA; Postapproval
Bioanalysis of Endogenous Compounds in PK BE Studies in ANDAs - Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development
Bioanalysis of the Dried Blood Spot (DBS) by Mass Spectrometry for Clinical Studies -Bioanalysis  Conference/Workshop 6/30/2020 Generic Drug Development
Bioanalysis of Unstable Analytes in Pharmacokinetic BE Studies for ANDAs - Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development
Bioanalytical Method Validation: History, Process, and Regulatory Perspectives - Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development
Case Study: Bioanalytical Approaches to Mitigate Issues during a BE Inspection - Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development
Common Deficiencies for Study Sample Reanalysis in PK BE for ANDAs - Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development
Considerations on ex vivo Conversion of Prodrugs during Bioanalysis - Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development
CREST Site Selection Model Overview - Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development
Keynote - Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development
Office of Clinical Pharmacology (OCP): Biosimilars - Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development
Office of Clinical Pharmacology (OCP): Drugs and Biologics - Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development
Office of Clinical Pharmacology (OCP): Panel Discussion - Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development
Office of Generic Drugs Panel Discussion - Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development
Office of Study Integrity and Surveillance Session (OSIS) Panel Discussion - Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development
Overview of Immunogenicity Inspections - Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development
Panel Discussion - Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development
Regulated Bioanalysis for Small Molecules - Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development
Regulated Bioanalysis of Large Molecules - Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development
Regulatory Education for Industry: Regulated Bioanalysis Workshop: Requirements and Expectations Conference/Workshop 6/30/2020 Generic Drug Development
What Meta-analysis Can Tell You about the Performance of Bioanalytical Methods - Bioanalysis   Conference/Workshop 6/30/2020 Generic Drug Development
Keynote: Pharmaceutical Quality: A Global Priority (CDER) (1/15) Global Quality Webinar 7/23/2020 Drug Quality; International
An International Commitment to Pharmaceutical Quality (2/15) Global Quality Webinar 7/23/2020 Drug Quality; International
Manufacturing Assessment and Application Action (3/15) Global Quality Webinar 7/23/2020 Drug Quality; International
Pre-Approval Inspections and Alternative Approaches to Facility Assessment (4/15) Global Quality Webinar 7/23/2020 Drug Quality; Inspections; International
An Overview of Pre-License Inspections for Biotech Products (5/15) Global Quality Webinar 7/23/2020 Drug Quality; Inspections; International
Panel Discussion (6/15) Global Quality Webinar 7/23/2020 Drug Quality; Inspections; International
FDA’s International Mission and the Global Manufacturing Landscape (7/15) Global Quality Webinar 7/23/2020 Drug Quality; International
Quality Management Maturity: FDA Vision & Expectations (8/15) Global Quality Webinar 7/23/2020 Drug Quality; International
Major Issues and Facilities in Drug Master Files (9/15) Global Quality Webinar 7/23/2020 Drug Quality; Drug Master Files; International
Pharmaceutical Quality Policies: What You Need to Know (10/15) Global Quality Webinar 7/23/2020 Drug Quality; International
Panel Discussion (11/15) Global Quality Webinar 7/23/2020 Drug Quality; Drug Master Files; International
FDA’s International Office and the Pharmaceutical Quality Mission (12/15) Global Quality Webinar 7/23/2020 Drug Quality; International
The State of Pharmaceutical Quality: Surveillance Findings (13/15) Global Quality Webinar 7/23/2020 Drug Quality; International
Successfully Implementing Advanced Manufacturing (14/15) Global Quality Webinar 7/23/2020 Drug Quality; International
Panel Discussion (15/15) Global Quality Webinar 7/23/2020 Drug Quality; International
A Pharmaceutical Quality Webinar for Global Stakeholders Webinar 7/23/2020 Drug Quality; International
CDER SEND Common Issues and Policy Update  Webinar 6/15/2020 Regulatory Submissions
Best Practices for Proprietary Name Design – Pharmacovigilance   Conference/Workshop 6/9/2020 Safety
Combination Products: Reporting Device Information and Malfunctions - Pharmacovigilance   Conference/Workshop 6/9/2020 Safety
Considerations for REMS Surveys and Assessments: Planning and Reporting - Pharmacovigilance   Conference/Workshop 6/9/2020 Safety
Designing User Interfaces to Prevent Medication Errors – Pharmacovigilance   Conference/Workshop 6/9/2020 Safety
Development of Shared System REMS & Implications of the Appropriations Act - Pharmacovigilance   Conference/Workshop 6/9/2020 Safety
Digital IND Safety Reporting - Pharmacovigilance   Conference/Workshop 6/9/2020 Safety; IND
Division of Risk Management: Overview of Review Activities and REMS - Pharmacovigilance   Conference/Workshop 6/9/2020 Safety
FDA Adverse Event Reporting System (FAERS) Overview - Pharmacovigilance   Conference/Workshop 6/9/2020 Safety
FDA's Sentinel Initiative - Pharmacovigilance   Conference/Workshop 6/9/2020 Safety
ICSR Data Quality of Coding: Products, Adverse Events and Medication Errors - Pharmacovigilance   Conference/Workshop 6/9/2020 Safety
Keynote – Pharmacovigilance and Risk Management Conference   Conference/Workshop 6/9/2020 Safety
Postmarket Safety Surveillance: Tools, Methods, and Benefit-Risk Framework - Pharmacovigilance   Conference/Workshop 6/9/2020 Safety
Preventing Medication Errors: Lessons Learned from Postmarket Safety Surveillance– Pharmacovigilance Conference/Workshop 6/9/2020 Safety
Process for Reviewing Nonproprietary Name Suffix for Biological Products – Pharmacovigilance   Conference/Workshop 6/9/2020 Safety
Questions and Discussion – Pharmacovigilance   Conference/Workshop 6/9/2020 Safety
REMS Integration Initiatives - Pharmacovigilance   Conference/Workshop 6/9/2020 Safety
Pharmacovigilance and Risk Management Conference – New Approaches, Tools, and Technologies Conference/Workshop 6/9/2020 Drug Development; Drug Safety
Monograph reform is here! Learn what to expect and how to prepare. Webinar 5/29/2020 Regulatory Submissions; OTC Drug Regulation
Still submitting paper to CDER? Send electronically with CDER’s NextGen Portal instead! Webinar 5/26/2020 Regulatory Submissions
Conducting Clinical Trials During the COVID-19 Public Health Emergency Webinar 4/30/2020 New Drug Development
Postmarketing Drug Safety Compliance: 2019 Inspection Findings  Webinar 4/29/2020 Safety; Inspections
Updates on FDA’s Drug-Drug Interaction Final Guidances Webinar 4/24/2020 New Drug Development; IND
Generic Drugs Forum - April 15&16, 2020 Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality
ANDA Program Performance Review and Tips (8/16) Generic Drugs Forum   Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality
Application Case Studies on FDA’s Action Letter Timing (16/16) Generic Drugs Forum Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality
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
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
Current Global Generic Drug Landscape (10/16) Generic Drugs Forum Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality
Electronic Submission of an ANDA Application and Study Data (7/16) Generic Drugs Forum   Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality
Facility Readiness: GMPs, Quality Assessments, and Compliance Trends (15/16) Generic Drugs Forum  Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality
Generic Combination Products: Assessment and Regulatory Update (14/16) Generic Drugs Forum Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality
Generic Drug Labeling: Recommendations for High-Quality Submissions (4/28) Generic Drugs Forum   Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality
ICH Q12 Guidance and Emerging Technology Program (11/16) Generic Drugs Forum   Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality
Keynote from the Office of Pharmaceutical Quality (OPQ) (2/16) Generic Drugs Forum   Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality
Keynote: Generic Drug Program Update (1/16) Generic Drugs Forum   Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality
New Programs and Requirements Under FDARA (5/16) Generic Drugs Forum   Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality
Pre-ANDA Interactions with the FDA (6/16) Generic Drugs Forum   Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality
Product Specific Guidances (PSGs) (3/16) Generic Drugs Forum   Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality
The Importance of Generic Drug Pharmacovigilance (9/16) Generic Drugs Forum   Conference/Workshop 4/15/2020 Generic Drug Development; Drug Quality
Learn About ClinicalTrials.gov Modernization and How to Provide Input Webinar 3/6/2020 Clinical Trials and Research
Recent Revisions to the ANDA Prioritization MAPP Webinar 1/30/2020 Generic Drug Development
Improving Regulatory Communication via the CDER NextGen Portal  SBIA Chronicles Podcast 12/29/2019 Regulatory Submissions
Improving Regulatory Communication via the CDER NextGen Portal  SBIA Chronicles 12/19/2019 Regulatory Submissions
What is new with Forms FDA 3542a and 3542? Webinar 12/11/2019 Regulatory Submissions
What is new with Forms FDA 3542a and 3542 Webinar 12/5/2019 Regulatory Submissions
2019 CDER Prescription Drug Labeling Conference - December 4-5, 2019 Conference/Workshop 12/4/2019 New Drug Development; Labeling
A Recipe for Clinical Pharmacology Information in Labeling (1/19)    Conference/Workshop 12/4/2019 Labeling
Adverse Reaction Information in Prescribing Information (3/19)    Conference/Workshop 12/4/2019 Labeling
Drug Product Nomenclature (15/19)    Conference/Workshop 12/4/2019 Labeling
Improving the Accuracy of SPL Submissions “The Missing LOINC” (9/19)    Conference/Workshop 12/4/2019 Labeling
Indications and Usage & Drug Abuse and Dependence Sections of Labeling (2/19)    Conference/Workshop 12/4/2019 Labeling
Instructions for Use (IFU) Content and Format Draft Guidance (13/19)    Conference/Workshop 12/4/2019 Labeling
Labeling Case Study: Transformation of an Indication (6/19)    Conference/Workshop 12/4/2019 Labeling
Labeling Finalization: Final Check of Prescribing Information (8/19)    Conference/Workshop 12/4/2019 Labeling
Labeling for Biological Products (11/19)    Conference/Workshop 12/4/2019 Labeling
Panel Questions and Discussion (10/19)    Conference/Workshop 12/4/2019 Labeling
Panel Questions and Discussion (16/19)    Conference/Workshop 12/4/2019 Labeling
Panel Questions and Discussion (19/19)    Conference/Workshop 12/4/2019 Labeling
Panel Questions and Discussion (7/19)    Conference/Workshop 12/4/2019 Labeling
Pediatric Information In Prescribing Information (4/19)    Conference/Workshop 12/4/2019 Labeling
Prescribing Information and Carton/Container Labeling Consistency (18/19)   Conference/Workshop 12/4/2019 Labeling
Product Title & Initial US Approval in the Highlights Section (14/19)    Conference/Workshop 12/4/2019 Labeling
Safety Considerations for Container Labels and Carton Labeling (17/19)    Conference/Workshop 12/4/2019 Labeling
The Pregnancy and Lactation Labeling Rule: Four Years In — What’s next? (5/19)    Conference/Workshop 12/4/2019 Labeling
Voluntary PLR Conversions and Updating Prescribing Information (1/19)    Conference/Workshop 12/4/2019 Labeling
2019 CDER Prescription Drug Labeling Conference Conference/Workshop 12/4/2019 Labeling
FDA Study Data Technical Conformance Guide v4.4 Webinar 11/22/2019 Regulatory Submissions
Clinical Investigator Training Course Conference/Workshop 11/12/2019 New Drug Development
Technical Specifications for Submitting Data for QT Studies  Webinar 11/8/2019 Regulatory Submissions
Submitting IND Safety Reports to FDA Adverse Event Reporting System (FAERS) Webinar 11/1/2019 Safety; IND; Regulatory Submissions
OPDP Electronic Submissions – Common Errors in eCTD and How to Avoid Them Webinar 10/25/2019 Regulatory Submissions; Marketing
Compliance Program and Case Study (7/8) Registration and Listing  Conference/Workshop 10/22/2019 Registration and Listing
Electronic Drug Registration and Listing Using CDER Direct  Conference/Workshop 10/22/2019 Registration and Listing
Establishment Registration and Labeler Code Requests (3/8) Registration and Listing  Conference/Workshop 10/22/2019 Registration and Listing
Keynote from the Drug Registration and Listing Staff (2/8) Registration and Listing  Conference/Workshop 10/22/2019 Registration and Listing
Listing Certification and Inactivation (6/8) Registration and Listing  Conference/Workshop 10/22/2019 Registration and Listing
NDC Reservation, Listing, 503B Compounded Product (5/8) Registration and Listing  Conference/Workshop 10/22/2019 Registration and Listing
Panel Questions and Discussion (4/8) Drug Registration and Listing Using CDER Direct  Conference/Workshop 10/22/2019 Registration and Listing
Panel Questions and Discussion (8/8) Registration and Listing  Conference/Workshop 10/22/2019 Registration and Listing
Welcome from CDER’s Office of Compliance (1/8) Registration and Listing  Conference/Workshop 10/22/2019 Registration and Listing
Application Manufacturing Assessment (4/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Assessment of the Multi-Attribute Method (MAM) Substance (23/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Biosimilars and Interchangeables - Regulatory Highlights (27/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Case Studies: Continuous Manufacturing of Drug Substance (21/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Change Management: ICH Q12 and Established Conditions (12/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Continuous Manufacturing of Drug Product (20/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Data Quality Expectations for Biosimilars with Case Studies (29/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Emerging Technology Program (18/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
End-to-end Integrated Continuous Manufacturing (25/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
FDA Perspectives on Biosimilar BLA-Manufacturing (28/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
FDA Research Supporting Emerging Technologies with Case Studies (24/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
FDA’s Quality Assessment and Knowledge Management - KASA (11/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
How Does FDA Execute Pre- and Post-approval Inspections? (7/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Integration of Assessment and Inspection for Biological Products (9/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Keynote: CDER’s Commitment to Pharmaceutical Quality (1/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Panel Questions and Discussion (10/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Panel Questions and Discussion (13/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Panel Questions and Discussion (17/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Panel Questions and Discussion (22/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Panel Questions and Discussion (26/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Panel Questions and Discussion (30/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Panel Questions and Discussion (33/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Panel Questions and Discussion (6/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Pharmaceutical Quality Surveillance Program (14/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Pharmaceutical Quality Symposium  Conference/Workshop 10/16/2019 Drug Quality
Policy Considerations for Continuous Manufacturing (19/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Policy Initiatives for Pharmaceutical Quality (5/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Quality Assessment of BLAs, NDAs, and ANDAs (3/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Quality Considerations for Transition Biological Products (32/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Quality Metrics, Quality Culture, and Data-Driven Decisions (16/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Quality-Related Compliance Actions and Trends (15/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
Small Molecule Case Studies (8/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
The “Deemed to be a License” Provision of the BPCI Act (31/33) Quality   Conference/Workshop 10/16/2019 Drug Quality; Biosimilars; BLA; NDA
The Importance of Quality in Our Medicines (2/33) Quality   Conference/Workshop 10/16/2019 Drug Quality
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
2019 Complex Generic Drug Product Development Workshop Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
BE Approaches for Long Acting Drug Products (14/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
BE for Bridging Studies with Orally Inhaled/Nasal Drugs (26/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Bioequivalence for Generic Topical and Transdermal (6/35) Complex Generics  Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
CMC Updates for Orally Inhaled Drugs (27/35) Complex Generics  Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Comparative Analyses: Device and User Interface (25/35) Complex Generics  Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Comparative Analyses: Injectable Combination Products (21/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Complex Peptide ANDAs: Test/Reference Comparability (11/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Considerations of Particle Analysis (12/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
CREdIbility for Computational Fluid Dynamics Models (33/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Dose-Scale Analysis in Pharmacodynamic Equivalence (31/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
FDA’s Inactive IngREdIent Database (IID) (3/f35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Generic Topical and Transdermal Products (5/35) Complex Generics  Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
In Vitro Drug Release Testing for LA Drug Products QC (16/35) Complex Generics  Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Keynote with Sally Choe (1/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Overview of Comparative Analyses - Clinical Perspective (19/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Panel Questions and Discussion (35/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Physiologically-based Pharmacokinetic Modeling (32/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
PK/PD Meta-analysis of Abuse Deterrent Opioid Drugs (30/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Pre-ANDA Meeting Requests for Orally Inhaled/Nasal Drugs(24/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Pre-ANDA Program Update (2/35) Complex Generics  Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
PSG Recommendations and Updates for OINDPs (23/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Quality for Transdermal Delivery Systems (8/35) Complex Generic Drugs   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Quality View on Injectable Product Considerations (20/35) Complex Generic Drugs   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Quantitative Clinical Pharmacology in LA Injectables (34/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Quantitative Methods and Modeling (29/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Questions and Answers (13/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Questions and Answers (17/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Questions and Answers (22/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Questions and Answers (28/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Questions and Answers (4/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Questions and Answers (9/35) Complex Generic Drugs   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Strategies for Generic Topical Product Development (7/35) Complex Generics  Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Strategies to Demonstrate Complex API Sameness (10/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
Strategies to Demonstrate Complex Excipient Sameness (15/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
What Constitutes Complex Drug-Device Combination (18/35) Complex Generics   Conference/Workshop 9/25/2019 Generic Drug Development; Drug Quality
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
Abbreviated Approval Pathways - 505(b)(2) or ANDA? SBIA Chronicles 9/19/2019 Generic Drug Development; NDA
Abbreviated Approval Pathways - 505(b)(2) or ANDA? SBIA Chronicles Podcast 9/19/2019 Generic Drug Development; NDA
Most Common Issues with CDISC-SEND Data in FDA Toxicology Review Webinar 9/12/2019 Regulatory Submissions
eCTD Submissions of Promotional Labeling and Advertising Materials Webinar 8/12/2019 Regulatory Submissions; Marketing
Risk-Based Approach to Monitoring Clinical Investigations: Overview of FDA Draft Guidance Issued for Comment Webinar 6/26/2019 Clinical Trials and Research
Research Investigational New Drug Applications – What You Need To Know SBIA Chronicles 6/25/2019 Clinical Trials and Research; IND
Research Investigational New Drug Applications – What You Need To Know SBIA Chronicles Podcast 6/25/2019 Clinical Trials and Research; IND
Bioanalytical Method Validation of ANDAs – What the Assessor Looks for During Inspections Webinar 6/17/2019 Generic Drug Development
Accuracy and Precision in Bioanalysis: Review of Case Studies  Webinar 6/17/2019 New Drug Development
Bioanalytical Method Validation (BMV) Panel Discussion Webinar 6/17/2019 New Drug Development
Bioanalytical Inspections: Overview and Case Studies  Webinar 6/17/2019 New Drug Development
How should I measure this? An FDA perspective on the Bioanalytical Method Validation (BMV) Webinar 6/17/2019 New Drug Development
The Finalized Bioanalytical Method Validation Guidance: What’s New For NDAs and BLAs  Webinar 6/17/2019 New Drug Development; NDA; BLA
Identification of Medicinal Products (IDMP): What is IDMP and Why Should I Care?  Webinar 6/13/2019 New Drug Development
CDER FDA Exclusivity – Which One Is for Me?  Webinar 6/10/2019 User Fees; NDA; BLA
FDA Orphan Drugs Program and Financial Incentives for CDER Medical Products Webinar 6/10/2019 User Fees; NDA; BLA
Financial Incentives for CDER Medical Products Webinar 6/10/2019 User Fees; NDA; BLA
Navigating the World of Biosimilar User Fees Webinar 6/10/2019 BLA; User Fees
Panel on Financial Incentives for CDER Medical Products - PDUFA & Biosimilars  Webinar 6/10/2019 User Fees; NDA; BLA
Prescription Drug User Fee Act Waivers, Exemptions, and Refunds -Oh My Webinar 6/10/2019 User Fees; NDA; BLA
A Medical Officer’s Approach to NDA/BLA Review (8/15) REdI Annual Conference  Conference/Workshop 5/29/2019 New Drug Development; IND; Resources
CDER Industry Assistance Resources (1/15) REdI  Conference/Workshop 5/29/2019 New Drug Development; IND; Resources
CDER’s Review of the Prescribing Information (11/15) REdI– May 29-30, 2019 Conference/Workshop 5/29/2019 New Drug Development; IND
CMC - NDA requirements and Common Pitfalls of BLAs (14/15) REdI  Conference/Workshop 5/29/2019 New Drug Development; IND
Components of New Drug Application and Biologics License Application (5/15) REdI Conference/Workshop 5/29/2019 New Drug Development; IND
Electronic Common Technical Document (eCTD) and Study Data (7/15) REdI  Conference/Workshop 5/29/2019 New Drug Development; IND
Meetings: Pre-submission and Special Programs (4/15) REdI Annual Conference  Conference/Workshop 5/29/2019 New Drug Development; IND
Navigating the World of Combination Products (2/15) REdI  Conference/Workshop 5/29/2019 New Drug Development; IND
NDA and BLA Application Review Process (6/15) REdI Annual Conference  Conference/Workshop 5/29/2019 New Drug Development; IND
Nonproprietary Name Suffix and Safety for Product Design and Labels (10/15) REdI  Conference/Workshop 5/29/2019 New Drug Development; IND
ORA Aligned for the Future (1/15) REdI  Conference/Workshop 5/29/2019 New Drug Development; IND
Pre-Approval Inspections: What to Expect When Being Inspected (15/15) REdI  Conference/Workshop 5/29/2019 New Drug Development; IND; Inspections
Ready to Launch: Essentials of Submitting Initial Materials to OPDP (12/15) REdI Conference/Workshop 5/29/2019 New Drug Development; IND; Marketing
Regulatory Education for Industry (REdI) Annual Conference - Focus on Essentials of NDAs and BLAs Conference/Workshop 5/29/2019 User Fees; NDA; BLA
Regulatory Highlights for Biosimilars and Interchangeables (9/15) REdI  Conference/Workshop 5/29/2019 New Drug Development; IND
What can CDER do for you? (3/15) REdI Annual Conference  Conference/Workshop 5/29/2019 New Drug Development; IND
Competitive Generic Therapies  SBIA Chronicles 5/23/2019 Generic Drug Development
Competitive Generic Therapies SBIA Chronicles Podcast 5/23/2019 Generic Drug Development
Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics: Overview of FDA Draft Guidance Issued for Comment Webinar 5/13/2019 New Drug Development; Real World Evidence
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
Deploying the MyStudies System in a Compliant Manner (8/9) MyStudies App  Webinar 5/9/2019 New Drug Development; Real World Evidence
Final Question and Answer Panel (9/9) MyStudies App Webinar 5/9/2019 New Drug Development; Real World Evidence
Introduction (1/9) FDA MyStudies Mobile App System  Webinar 5/9/2019 New Drug Development; Real World Evidence
Mobile Application and WCP: Usability and Technical Overview (5/9) FDA MyStudies App Webinar 5/9/2019 New Drug Development; Real World Evidence
Patient and Researcher Experiences: A Demonstration (2/9) FDA MyStudies App  Webinar 5/9/2019 New Drug Development; Real World Evidence
Patient and Researcher Experiences: Demo of the FDA MyStudies Mobile App (3/9)  Webinar 5/9/2019 New Drug Development; Real World Evidence
Question and Answer Panel (7/9) MyStudies App  Webinar 5/9/2019 New Drug Development; Real World Evidence
Question and Answer Session Martin and Wyner (4/9) FDA MyStudies App Webinar 5/9/2019 New Drug Development; Real World Evidence
Response Server Technical Overview (6/9) FDA MyStudies App  Webinar 5/9/2019 New Drug Development; Real World Evidence
505(b)(2) NDA or ANDA? (10/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Assessment Tips (17/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Case Studies: Inadequate Bioequivalence Studies (18/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Complex Product Development (3/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Continuous Manufacturing with a Generic Perspective (25/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Decrease RTR, IR, and CR Due to Dissolution Deficiencies (21/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Deficiencies and Observations from Facility Evaluations and Inspections(27/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Drug Master Files (DMFs) from an ANDA Perspective (7/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Filing and Refuse to Receive (RTR) (16/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Generic Drug Forum: April 3-4, 2019 Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Impurity Case Studies: Pharmacology/Toxicology (22/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Keynote: Generic Drug Program Update (1/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Manufacturing Process and Controls: Avoiding Assessment Issues (26/28) Generic Drug Forum   Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Mid-cycle Assessment and Post-complete Response Letter Meetings (6/28) Generic Drug Forum Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Orange Book - Its Role in ANDAs (8/28) Generic Drug Forum Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Practical Tips on eCTD (13/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Pre-ANDA Meeting or Controlled Correspondence? (4/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Questions and Answers (11/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Questions and Answers (15/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Questions and Answers (19/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Questions and Answers (23/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Questions and Answers (28/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Questions and Answers (5/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Referencing Approved Drug Products in ANDA Submissions (9/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Stability Case Studies (20/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
The Importance of Quality in Our Medicines (2/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Tips on Using the CDER NextGen Collaboration Portal (12/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Types of Fees and Q&A (24/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
Update on Technical Rejection Criteria for Study Data (14/28) Generic Drug Forum  Conference/Workshop 4/3/2019 Generic Drug Development; Drug Quality
A New Era for Homeopathic Drug Product Regulation  SBIA Chronicles Podcast 3/22/2019 New Drug Development
Framework for FDA’s Real-World Evidence Program  Webinar 3/15/2019 New Drug Development; Real World Evidence
Human Drug Establishment Registration and Drug Listing Compliance; CDERLearn Course CDERLearn Course 3/12/2019 Registration and Listing
FDA Modernizes Clinical Trials with Master Protocols SBIA Chronicles 2/26/2019 New Drug Development; IND; Clinical Trials and Research
FDA Modernizes Clinical Trials with Master Protocols SBIA Chronicles Podcast 2/26/2019 New Drug Development; IND; Clinical Trials and Research
Final Guidance for Industry: Use of Electronic Health Record Data in Clinical Investigations  Webinar 12/6/2018 Clinical Trials and Research; Regulatory Submissions
Early Engagement with FDA to Discuss Novel Surrogate Endpoints SBIA Chronicles 11/27/2018 New Drug Development; FDA Meetings/Communications
Early Engagement with FDA to Discuss Novel Surrogate Endpoints  SBIA Chronicles Podcast 11/27/2018 New Drug Development; FDA Meetings/Communications
FDA Study Data Technical Conformance Guide Webinar 11/27/2018 Regulatory Submissions
Clinical Investigator Training Course (CITC) 2018: November 13 - 15, 2018 Conference/Workshop 11/13/2018 New Drug Development; Clinical Trials
FDA Facilitates the Use of Surrogate Endpoints in Drug Development SBIA Chronicles 11/5/2018 Clinical Trials and Research; IND
FDA Facilitates the Use of Surrogate Endpoints in Drug Development  SBIA Chronicles Podcast 11/5/2018 Clinical Trials and Research; IND
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
Blinding of Bioequivalence Trials (9/11) GCP Data Integrity Conference/Workshop 10/23/2018 Clinical Trials and Research
Data Integrity from International Perspectives (2/11) GCP Data Integrity Workshop Conference/Workshop 10/23/2018 Clinical Trials and Research
Data Quality: Why Do We Care? (1/11) GCP Data Integrity Conference/Workshop 10/23/2018 Clinical Trials and Research
Effective Use of Audit Trails (10/11) GCP Data Integrity Workshop Conference/Workshop 10/23/2018 Clinical Trials and Research
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
Good Clinical Practice Assessment of Data Reliability in Registration Trials (5/11) GCP Data Conference/Workshop 10/23/2018 Clinical Trials and Research
Overview of Data Integrity (4/11) GCP Data Integrity Workshop Conference/Workshop 10/23/2018 Clinical Trials and Research
Quality and Control of Clinical Trial Data (6/11) GCP Data Integrity Workshop Conference/Workshop 10/23/2018 Clinical Trials and Research
Quality Management Systems and Quality By Design (3/11) GCP Data Integrity Workshop Conference/Workshop 10/23/2018 Clinical Trials and Research
The Data Management Plan – Pulling It All Together (7/11) GCP Data Integrity Workshop Conference/Workshop 10/23/2018 Clinical Trials and Research
Unblinding – Let Me Count the Ways… (8/11) GCP Data Integrity Conference/Workshop 10/23/2018 Clinical Trials and Research
Electronic Drug Registration and Listing Using CDER Direct: October 2, 2018 Conference/Workshop 10/2/2018 Registration and Listing
Writing the “Indications and Usage” Section of Labeling: FDA’s New Draft Guidance  Webinar 9/27/2018 Labeling
Real-Time Review of Drug Applications is Now a Reality SBIA Chronicles 9/20/2018 IND; NDA
Real-Time Review of Drug Applications is Now a Reality SBIA Chronicles Podcast 9/20/2018 IND; NDA
Complex Generic Drug Product Development Workshop Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
Common Issues in Complex Drug Substance Review (8of39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
Considerations for Establishing Q1/Q2 Sameness of Complex Formulations (10/39) Complex Generics '18 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
Considerations in Demonstrating Complex API Sameness (7/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
Equivalence testing of complex particle size distribution profiles-earth mover’s distance (15/39) Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
Establishing Appropriate BE Limits for Complex Formulations (14/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
In vitro bioequivalence testing for topical ophthalmic suspension products (17/39) Complex Generics Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
In Vitro Release Testing of Complex Formulations (11/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
Iron Colloid Drug Products: Characterization and Impurity (13/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
Multivesicular Liposomes: Physicochemical characterization & in vitro drug release testing (12/39) Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
Office of Generic Drugs Keynote (1/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
PBPK modeling and simulation used in assessing BE for generic ophthalmic products (19/39)  Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
Peptide Drug Challenges through Pre-ANDA Processes & Case Studies (6/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
Pre-ANDA Logistics and Best Practices (3/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
Pre-ANDA Program Overview (2/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
Pre-ANDA review: Office of Pharmaceutical Quality (OPQ) (4/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
Product Quality Testing for Topical Ophthalmic Suspension Products (18/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
Questions and Panel Discussion (16/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
Questions and Panel Discussion (20/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
Questions and Panel Discussion (5/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
Questions and Panel Discussion (9/39) Complex Generics 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
Complex Generic Drug Product Development Workshop - September 12-13, 2018 Conference/Workshop 9/12/2018 Generic Drug Development; Drug Quality
The FAERS Public Dashboard and its Value to the Pharmaceutical Industry  SBIA Chronicles 7/10/2018 Safety
The FAERS Public Dashboard and its Value to the Pharmaceutical Industry SBIA Chronicles Podcast 7/10/2018 Safety
Postmarketing Drug Safety and Inspection Readiness - June 19, 2018 Deeper Dive Webinar Webinar 6/19/2018 Inspections; Safety; Postapproval
BIMO, REMS, and PADE Inspection Readiness (3/3) Webinar 6/19/2018 Safety; Inspections; Postapproval
Postmarketing Adverse Drug Experience (PADE) Inspections – (1/3)  Webinar 6/19/2018 Safety; Inspections; Postapproval
Risk Evaluation and Mitigation Strategies (REMS) Inspections (2/3)  Webinar 6/19/2018 Safety; Inspections; Postapproval
Benefit-Risk Considerations During Drug Product Development (8/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA
CDER Small Business and Industry Assistance Overview (12/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA; Resources
Chemistry, Manufacturing, and Controls (CMC) for an IND (7/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA
Demystifying the Investigational New Drug (IND) Application for Drugs and Biologics (3/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA
FDA Regulatory Requirements for Clinical Investigators and Case Examples (9/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA
Formal Meetings for PDUFA Products and Communication Best Practices (4/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA
Good Manufacturing Practices (GMPs) from an IND Perspective (11/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA
Human Factors Engineering in Medical Products Reviews (2/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA
Investigational New Drug (IND) Submission: Content/Format and First 30 Days (5/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA
Investigational New Drug Safety Reporting Requirements (10/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA
Nonclinical Safety Assessment for Small Molecules and Biologic Drug Development (6/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA
Office of Regulatory Affairs Update (1/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA
Panel Discussion (27/27) Generic Drugs Forum April 11-12, 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA
The Active IND and Available Development Programs (13/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA
Walkthrough of a Pre-Approval Manufacturing Site Inspection (14/14) REdI 2018 Conference/Workshop 5/18/2018 Drug Development; IND; NDA
Regulatory Education for Industry (REdI) Spring Conference:  May 15-16, 2018 Conference/Workshop 5/15/2018 New Drug Development; IND
Optimizing Your Data Submissions to FDA: Office of Vaccines Research and Review (OVRR) Data Submission Webinar 5/8/2018 Regulatory Submissions
Updates to Forms 356h & 1571: Commercial vs. Research Systematized Nomenclature of Medicine Clinical Terms (SNOMED CT) Combination Products Webinar 5/4/2018 Regulatory Submissions
ANDA Performance/Operations Update (3/27) Generic Drugs Forum April 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
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
Best Practices for Conducting Bioequivalence Studies (16/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
Bioequivalence Site and Manufacturing Facility Information in Applications (17/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
Challenges in Generic Drug Safety and Surveillance (6/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
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
Drug Substance Quality Assessment: Best Practices (23/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
Electronic Submissions (7/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Regulatory Submissions
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
GDUFA II – Review Timelines (14/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
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
GDUFA II User Fees: Update on Year One (21/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
Generic Drug Product Quality Assessment (22/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
Generic Drugs Forum: April 11 -12, 2018 Conference/Workshop 4/11/2018 Generic Drug Development
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
Integrated Process and Facilities Assessment (26/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
Integrated Quality Assessment Process (19/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
Keynote Address by Dr. Uhl (1/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
Laboratory Science to Support Risk-Based Quality Assessments (25/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
Microbiology Quality Assessment (18/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
Office of Pharmaceutical Quality (OPQ) Policy Update (4/27) Generic Drugs Forum April 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
Orange Book: 101 An Overview (11/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
Panel Discussion (13/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
Panel Discussion (20/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
Panel Discussion (9/27) Generic Drugs Forum 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
Pharmaceutical Quality Update by Dr. Michael Kopcha (2/27) Generic Drugs Forum April 2018 Conference/Workshop 4/11/2018 Generic Drug Development; Drug Quality
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
A New Era for Homeopathic Drug Product Regulation SBIA Chronicles 3/22/2018 New Drug Development
A New Era for Homeopathic Drug Product Regulation SBIA Chronicles Podcast 3/22/2018 New Drug Development
FDA Helping the Generic Industry Submit Complete Applications SBIA Chronicles 2/6/2018 Generic Drug Development; Regulatory Submissions
FDA Helping the Generic Industry Submit Complete Applications SBIA Chronicles Podcast 2/6/2018 Generic Drug Development; Regulatory Submissions
Draft guidance for Industry: Information Requests and Discipline Review Letters Under GDUFA Webinar 12/18/2017 Generic Drug Development; Regulatory Submissions
REMS Integration Initiative: An Overview Webinar 12/4/2017 Safety
PDUFA VI - A Time for Change SBIA Chronicles 11/28/2017 User Fees; NDA 
PDUFA VI - A Time for Change  SBIA Chronicles Podcast 11/28/2017 User Fees; NDA 
Optimizing Your Study Data Submissions to FDA –Study Data Technical Conformance Guide October 2017 Version Update Webinar 11/8/2017 Regulatory Submissions
Prescription Drug Labeling Conference 2017 Conference/Workshop 11/2/2017 Labeling
Draft Guidance for Industry: Controlled Correspondence Related to Generic Drug Development Webinar 11/2/2017 Generic Drug Development
PLR Implementation, CDER Staff for Labeling Review, and Resources (1/9) Prescription Drug Labeling 2017 Conference/Workshop 11/2/2017 Labeling
Consistency, Optimizing Communication, and Best Labeling Practices (2/9) Prescription Drug Labeling 2017 Conference/Workshop 11/2/2017 Labeling
Considerations for Developing the Indications and Usage Section of Labeling (3/9) Labeling 2017 Conference/Workshop 11/2/2017 Labeling
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
Novel and Adaptive Labeling Approaches: PLR and Beyond (5/9) Labeling 2017 Conference/Workshop 11/2/2017 Labeling
Cracking the Code for Clinical Pharmacology-Related Prescription Drug Labeling (6/9) Prescription Drug Labeling 2017 Conference/Workshop 11/2/2017 Labeling
Overview of SPL and Challenges with Medication Guide Extraction and Data Mining (7/9)Prescription Drug Labeling 2017 Conference/Workshop 11/2/2017 Labeling
Lessons Learned with the Pregnancy and Lactation Labeling Rule (PLLR) (8/9) Prescription Drug Labeling 2017 Conference/Workshop 11/2/2017 Labeling
Safety Considerations for Patient Instructions to Minimize Medication Errors (9/9) Labeling 2017 Conference/Workshop 11/2/2017 Labeling
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
Draft Guidance for Industry: Determining Whether to Submit an ANDA or 505(b)(2) Application Webinar 10/13/2017 Generic Drug Development; NDA
Electronic Drug Registration & Listing Using CDER Direct: Extended Webinar Webinar 10/5/2017 Registration and Listing
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
Regulatory Education for Industry (REdI): Fall Conference: September 27-28, 2017 Conference/Workshop 9/27/2017 New Drug Development; IND
Keynote (1/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND
Plenary: Regulatory Research at FDA (2/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND
Introduction to Investigational New Drug (IND) Applications (3/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND
FDA Communication During Drug Development (4/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND; FDA Meetings/Communications
Regulatory and Administrative Components of an IND Application (5/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND; Regulatory Submissions
Benefit-Risk Considerations in Drug Development (6/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND
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
Overview of Non-clinical Assessment in Drug Development (8/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND
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
Additional Sponsor Responsibilities (10/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND
Overview of Clinical Investigator Responsibilities and Inspectional Findings (11/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND
Walkthrough of an FDA Clinical Investigator Site Inspection (12/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND; Inspections
Overview of FDA's Expanded Access Program (13/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND
Live Demo of the FDA Adverse Events Reporting System (14/14) REdI 2017 Conference/Workshop 9/27/2017 New Drug Development; IND; Drug Safety
Real-World Data and Evidence in Drug Development  SBIA Chronicles 8/24/2017 New Drug Development
Electronic Common Technical Document (eCTD): CDERLearn Course CDERLearn Course 8/3/2017 Regulatory Submissions
Optimizing Your Study Data Submissions to FDA – Updates from CDER and CBER  Webinar 7/13/2017 Regulatory Submissions
Updates to the Study Data Technical Conformance Guide (1/4) Technical Conformance  Webinar 7/13/2017 Regulatory Submissions
Providing Clinical Study Data to the Office of Vaccines (2/4) Tech Conformance   Webinar 7/13/2017 Regulatory Submissions
Biologics Quality Bioresearch and Study Data Submissions (3/4) Technical Conformance  Webinar 7/13/2017 Regulatory Submissions
Panel Questions and Discussion (4/4) Study Data Technical Conformance Webinar   Webinar 7/13/2017 Regulatory Submissions
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
Presenting Clinical Pharmacology Information in Prescription Drug Labeling  Webinar 6/19/2017 Labeling
Risk Evaluation and Mitigation Strategies (REMS): A Deeper Dive Webinar 6/15/2017 New Drug Development; Safety
REMS Purpose, Process, and Challenges (1/2) REMS Webinar  Webinar 6/15/2017 New Drug Development; Safety
Structured Product Labeling Format: An Introduction (2/2) REMS Webinar  Webinar 6/15/2017 New Drug Development; Safety; Regulatory Submissions
Submitting Master Files in eCTD Format: When and How to Comply SBIA Chronicles  5/25/2017 Drug Master Files; Regulatory Submissions
Submitting Master Files in eCTD Format: When and How to Comply  SBIA Chronicles Podcast 5/25/2017 Drug Master Files; Regulatory Submissions
Regulatory Education for Industry (REdI): Spring Conference: May 9-10, 2017 Conference/Workshop 5/9/2017 New Drug Development; IND
The Complexities of Compounding  SBIA Chronicles  4/20/2017 Compounding
The Complexities of Compounding SBIA Chronicles Podcast 4/20/2017 Compounding
Generic Drugs Forum: April 4-5, 2017 Conference/Workshop 4/4/2017 Generic Drug Development
Keynote – Office of Generic Drugs (1/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development
Keynote – Office of Pharmaceutical Quality (2/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality
ANDA Performance/Operations Update (3/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development
Office of Pharmaceutical Quality Policy Update (4/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality
GDUFA Regulatory Science Research Update (5/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development
Preparing for GDUFA II User Fees (6/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development
eCTD (7/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Regulatory Submissions
Panel Discussion (8/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Regulatory Submissions; Drug Quality
GDUFA II (9/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; User Fees
Development of Single, Shared System REMS (10/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Safety
Introduction to “The ANDA Review Pathway” (11/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development
ANDA Policy and Regulatory Considerations Prior to Filing (12/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development
Panel Discussion (13/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development
Filing Review – Do’s and Don’ts (14/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Regulatory Submissions
RPM Communications Associated with “Take Action” Process (15/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development
FDA’s Bioequivalence Recommendations for Generic Drugs (16/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development
Review of Clinical Endpoint Bioequivalence Studies in ANDAs (17/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development
Generic Labeling: Strategies for Providing High-quality Submissions (18/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Labeling
Panel Discussion (19/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development
OPQ Integrated Quality Assessment (IQA) Process (20/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality
OPQ Communications with Industry (21/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality
Drug Substance Review - ANDA (22/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality
Generic Drug Product Quality Review (23/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality
Dissolution Method Development for Generic Drugs (24/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality
Manufacturing Process and Controls (25/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality
Facility Evaluation and Inspection (26/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality; Inspections
Product Quality Microbiology Assessment (27/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality
Panel Discussion (28/28) Generic Drugs Forum 2017 Conference/Workshop 4/4/2017 Generic Drug Development; Drug Quality; Inspections
CDER Microbiology Issues: A Deeper Dive Webinar 3/15/2017 Drug Quality
Microbiology Assessment: Recommendations for Nonsterile Products (1/6) Microbiology Webinar Webinar 3/15/2017 Drug Quality
Case Study: Micro Investigation of Contamination by Burkholderia multivorans (2/6) Microbiology Webinar Webinar 3/15/2017 Drug Quality
Panel Questions and Discussion (3/6) CDER Microbiology Webinar  Webinar 3/15/2017 Drug Quality
Building a Better Sterility Assurance Application (4/6) CDER Microbiology Webinar  Webinar 3/15/2017 Drug Quality
Aseptic Processing of Biological Products: Regulatory Issues (5/6) Microbiology Webinar Webinar 3/15/2017 Drug Quality
Panel Questions and Discussion (6/6) CDER Microbiology Webinar  Webinar 3/15/2017 Drug Quality
Draft Guidance for Industry: Referencing Approved Drug Products in ANDA Submissions Webinar 3/6/2017 Generic Drug Development
Best Practices for Communication Between FDA and IND Sponsors During Drug Development: CDERLearn Course CDERLearn Course 2/1/2017 FDA Meetings/Communications; IND
FDA Addresses Small Business Concerns in GDUFA II  SBIA Chronicles 1/26/2017 Generic Drug Development
FDA Addresses Small Business Concerns in GDUFA II SBIA Chronicles Podcast 1/26/2017 Generic Drug Development
FDA's Role in Public Health: Drug Efficacy, Safety, Quality, and Beyond: CDERLearn Course CDERLearn Course 6/7/2021 New Drug Development; Safety; Quality 
GDUFA Self-Identification (SPL) Submission – Part 1: CDERLearn Course CDERLearn Course 1/12/2016 Generic Drug Development; Regulatory Submissions
GDUFA Self-Identification (SPL) Submission – Part 2: CDERLearn Course  CDERLearn Course 1/12/2016 Generic Drug Development; Regulatory Submissions
Overview of the Generic Drug User Fee Amendments of 2012 (GDUFA): CDERLearn Course CDERLearn Course 1/12/2016 Generic Drug Development; User Fees
Case Studies in FDA's Drug Regulatory Processes: CDERLearn Course CDERLearn Course 10/22/2015 New Drug Development; NDA; IND
Engaging with the FDA During New Drug Development CDERLearn Course 9/26/2014 New Drug Development; FDA Meetings/Communications
Chemistry, Manufacturing, and Controls (CMC) Perspective of the IND: CDERLearn Course CDERLearn Course 9/17/2014 New Drug Development; Drug Quality
Bringing an Over-the-Counter Drug to Market: CDERLearn Course CDERLearn Course 2/7/2013 OTC Drug Regulation
CDER Presentations Library Webinar   New Drug Development; Generic Drug Development; Biosimilars; Clinical Trials and Research
CDER Webinars Webinar   New Drug Development; Generic Drug Development; Biosimilars; Clinical Trials and Research
Guidance Webinar Series Webinar   New Drug Development; Generic Drug Development; Biosimilars; Clinical Trials and Research

Program Overview

Get Email Updates: Drugs Small Business and Industry Assistance

Get regular FDA email updates delivered on this topic to your inbox.

Back to Top