April 9-10, 2025
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
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
- Product-Specific Guidances for Generic Drug Development
- Pharmaceutical Quality Resources
- Industry Resources
- Guidances Related to Generic Drugs (under topics, choose “generic drugs”)
- Federal Register Notices Related to Generic Drugs
- GDUFA Science and Research
- Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book
visit the FDA.gov webpage
Enroll in the Generic Drugs Forum 2025 Course
Enroll in the Generic Drugs Forum 2025 course to access all lessons and resources.
Create a free FDA Learning Cache account or sign in with your existing account to get started.