Forum | Mixed
Event Title
Generic Drugs Forum (GDF) 2025
April 9 - 10, 2025
- Date:
- April 9 - 10, 2025
- Day1:
- Wed, Apr 9
- Day2:
- Thu, Apr 10
Visit CDER Small Business and Industry Assistance Page
Day One YouTube Livestream Recording
Day Two YouTube Livestream Recording
About this Event (Hosted by CDER SBIA)
Join us at the annual Generic Drugs Forum, 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.
Take advantage of this unique opportunity to interact with FDA experts, learn from industry peers, and stay up to date on the latest regulatory developments.
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
FDA 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