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FDA Generic Drugs Forum 2025

April 9-10, 2025

 

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Welcome & Keynotes

Office of Generic Drugs Keynote (Generic Drugs Forum 2025)
Lesson 1 of 2 within section Welcome & Keynotes.
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Office of Pharmaceutical Quality Keynote (Generic Drugs Forum 2025)
Lesson 2 of 2 within section Welcome & Keynotes.
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Supporting Resources – Access with FREE Enrollment (above)

Download Agenda, Slides & Transcripts (Generic Drugs Forum 2025)
Lesson 1 of 1 within section Supporting Resources – Access with FREE Enrollment (above). You must enroll in this course to access course content.
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Day 1, Session 1

ANDA Missed Goal Dates: An Update on Metrics and Internal Communications
Lesson 1 of 5 within section Day 1, Session 1.
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Transparency Pilot for Enhanced Communications (Generic Drugs Forum 2025)
Lesson 2 of 5 within section Day 1, Session 1.
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Request For Reconsideration: Process Overview and Best Practices for FDA Evaluation
Lesson 3 of 5 within section Day 1, Session 1.
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Request for Reconsideration – Overview and Experience from Bioequivalence Perspectives
Lesson 4 of 5 within section Day 1, Session 1.
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Day 1, Session 1 Q&A (Generic Drugs Forum 2025)
Lesson 5 of 5 within section Day 1, Session 1. You must enroll in this course to access course content.
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Day 1, Session 2

Best Practices for Generic Drug Labeling
Lesson 1 of 4 within section Day 1, Session 2.
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Project Managing Drug Assessors Under GDUFA III Regulations
Lesson 2 of 4 within section Day 1, Session 2.
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Minor Regulatory Errors with Major Consequences
Lesson 3 of 4 within section Day 1, Session 2.
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Day 1, Session 2 Q&A (Generic Drugs Forum 2025)
Lesson 4 of 4 within section Day 1, Session 2. You must enroll in this course to access course content.
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Day 1, Session 3

Considerations when Submitting Proposed Excipient Levels in Inactive Ingredient Controlled Correspondences
Lesson 1 of 4 within section Day 1, Session 3.
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Assessment of Inactive Ingredients in Generic Drug Applications: Building a Global Understanding
Lesson 2 of 4 within section Day 1, Session 3.
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How to Leverage the Inactive Ingredient Database (IID) and Safety Justification
Lesson 3 of 4 within section Day 1, Session 3.
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Day 1, Session 3 Q&A (Generic Drugs Forum 2025)
Lesson 4 of 4 within section Day 1, Session 3. You must enroll in this course to access course content.
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Day 1, Session 4

Product Specific Guidance (PSG) Program Overview
Lesson 1 of 5 within section Day 1, Session 4.
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Pre-Abbreviated New Drug Application (ANDA) Meetings: Process and Best Practices
Lesson 2 of 5 within section Day 1, Session 4. You must enroll in this course to access course content.
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Experiences from Post-Complete Response Letter (CRL) Scientific Meetings in GDUFA III
Lesson 3 of 5 within section Day 1, Session 4.
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Common Discrepancies Observed on the Form 356h with the Abbreviated New Drug Application (ANDA) Submission
Lesson 4 of 5 within section Day 1, Session 4.
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Day 1, Session 4 Q&A (Generic Drugs Forum 2025)
Lesson 5 of 5 within section Day 1, Session 4. You must enroll in this course to access course content.
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Day 2, Session 1

General Quality Considerations of Drug Products Labeled for Alternate Dosing Administration
Lesson 1 of 4 within section Day 2, Session 1.
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Nitrosamine Related Guidance
Lesson 2 of 4 within section Day 2, Session 1.
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Bioequivalence Approaches for Nitrosamine Impacted Generic Drug Applications: Case Studies
Lesson 3 of 4 within section Day 2, Session 1.
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Day 2, Session 1 Q&A (Generic Drugs Forum 2025)
Lesson 4 of 4 within section Day 2, Session 1. You must enroll in this course to access course content.
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Day 2, Session 2

Impact of ICH M13A Implementation on Bioequivalence Assessment: Removal of Data Due to Low Exposure
Lesson 1 of 5 within section Day 2, Session 2.
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ANDA Common Major Deficiencies
Lesson 2 of 5 within section Day 2, Session 2.
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Common Bioequivalence (BE) Deficiencies Identified in ANDAs Associated with Solid Oral Extended-Release Drug Products in Various Therapeutic Areas
Lesson 3 of 5 within section Day 2, Session 2.
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Common Clinical Deficiencies in Abbreviated New Drug Applications (ANDAs) Containing Comparative Clinical Endpoint Studies
Lesson 4 of 5 within section Day 2, Session 2.
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Day 2, Session 2 Q&A (Generic Drugs Forum 2025)
Lesson 5 of 5 within section Day 2, Session 2. You must enroll in this course to access course content.
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Day 2, Session 3

GDUFA III Impact on Drug Master File (DMF) Assessment
Lesson 1 of 5 within section Day 2, Session 3.
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Common Deficiencies in Drug Master Files (DMFs)
Lesson 2 of 5 within section Day 2, Session 3.
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Common (OPQ) Deficiencies in Abbreviated New Drug Applications (ANDAs)
Lesson 3 of 5 within section Day 2, Session 3.
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Navigating Challenges in Drug Manufacturing: Common Process Deficiencies and Pre-Approval Inspection Observations
Lesson 4 of 5 within section Day 2, Session 3.
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Day 2, Session 3 Q&A (Generic Drugs Forum 2025)
Lesson 5 of 5 within section Day 2, Session 3. You must enroll in this course to access course content.
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Day 2, Session 4

Orange Book Marketing Status
Lesson 1 of 5 within section Day 2, Session 4.
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Case Studies of Using Alternate Reference Products or Alternative Bioequivalence (BE) Approaches in Abbreviated New Drug Application (ANDA) Submissions
Lesson 2 of 5 within section Day 2, Session 4.
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Common Bioequivalence (BE) Information Requests (IRs): Tips for Facilitating the Review Process
Lesson 3 of 5 within section Day 2, Session 4.
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Day 2, Session 4 Q&A (Generic Drugs Forum 2025)
Lesson 4 of 5 within section Day 2, Session 4. You must enroll in this course to access course content.
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Closing Remarks (Generic Drugs Forum 2025)
Lesson 5 of 5 within section Day 2, Session 4.
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About This Course

The annual Generic Drugs Forum is a two-day event designed to facilitate the development and approval of safe, effective, and high-quality generic medicines. This premier event brings together FDA subject matter experts from every aspect of the pre-ANDA and ANDA assessment programs, offering unparalleled insights and guidance. Attendees will gain practical regulatory knowledge to enhance their applications, streamline the assessment process, and reduce cycles. The forum’s primary goal is to support prospective and current applicants in submitting complete and high-quality submissions, ultimately ensuring timely access to affordable medications that benefit public health.

Intended Audience

The generic drug industry, consultants, regulatory affairs professionals, or contractors with an emphasis on those who are:

  • involved in generic drug development
  • submitting or have submitted a generic drug application, amendment, supplement, or post-approval submission

Course Information

Categories: ,

Topics Covered

The Generic Drug Forum 2025 curriculum covers a comprehensive range of topics critical to generic drug development and the Abbreviated New Drug Application (ANDA) process, aligning with the objectives of the Generic Drug User Fee Amendment (GDUFA) III. Key areas explored include:

  • ANDA Submission and Review
  • Bioequivalence (BE)
  • Product Quality
  • Communication and Regulatory Pathways
  • Key Resources and Initiatives

Resources

visit the FDA.gov webpage

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