Forum | Mixed
Event Title
Generic Drugs Forum (GDF) 2026
April 22 - 23, 2026
- Date:
- April 22 - 23, 2026
- Day1:
- Wed, Apr 22
- Day2:
- Thu, Apr 23
Visit CDER Small Business and Industry Assistance (SBIA) Homepage
Day 1 Livestream Recording: https://www.youtube.com/watch?v=3zF6vTTEOj4
Day 2 Livestream Recording: https://www.youtube.com/watch?v=H-QLGRcJYj0
Keynote Speakers
Darby Kozak, PhD
Deputy Director
Office of Generic Drugs
CDER | FDA
Susan Rosencrance, PhD
Deputy Director for Science
Office of Pharmaceutical Quality
CDER | FDA
About this Event (Hosted by CDER SBIA)
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
- Controlled Correspondence
- Pre-ANDA Submissions and Meetings
- ANDA Submissions, Assessments, and Meetings
- Quality and Manufacturing
- Drug Master Files
- Advanced Topics and Case Studies
- …Many others
Resources
- GDUFA guidances
- Manual of Policies & Procedures (MAPPs), which are documents that describe internal policies and procedures that are made available to the public to increase transparency, on its MAPP website
- Other helpful information, including recorded webinars on GDUFA topics, can be found on FDA’s GDUFA III website
- Specific questions regarding the development of a generic drug product not yet submitted in an ANDA: please submit a controlled correspondence