U.S. flag An official website of the United States government

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

U.S. Food and Drug Administration
  1. Home
  2. Drugs
  3. Generic Drugs Forum (GDF) 2025 - 04/09/2025
  1. Drugs

Forum | Mixed

Event Title
Generic Drugs Forum (GDF) 2025
April 9 - 10, 2025

Date:
April 9 - 10, 2025
Day1:
Wed, Apr 09 8:30 a.m. - 05:00 p.m. ET
Day2:
Thu, Apr 10 8:30 a.m. - 05:00 p.m. ET
Location:
Event Location
Bethesda North Marriott
Hotel & Conference Center

5701 Marinelli Road
Rockville, MD 20852
United States


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.

Register for this Event
Plan to attend in person at The Bethesda North Marriott, Rockville, MD.
 

Book Your Room Early
Room block will close on Tuesday, March 11, 2025, or when the block is full.
 

Agenda
Coming soon
 

Visit CDER Small Business and Industry Assistance (SBIA) Homepage

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

Continuing Education

Real-time attendance is required for the certificate of attendance which can be used in support of CEs for the following professional organizations. Certificates are only available during the two weeks post-event.

This course has been pre-approved by:

  • RAPS as eligible for a maximum of 12 credits for a two-day event (appropriate to real-time attendance) towards a participant’s RAC recertification upon full completion.
  • SOCRA who accepts documentation of candidate participation in continuing education programs for re-certification if the program is applicable to clinical research regulations, operations or management, or to the candidate's clinical research therapeutic area.
  • SQA as eligible for 1 non-GCP or non-GLP unit for every 1 hour of instructional time towards a participant’s RQAP re-registration.
  • ACRP for continuing education in clinical research. ACRP will provide 1 ACRP contact hour for every 45-60 minutes of qualified material.

Technical Information

  • To optimize your webinar experience, use Chrome when viewing Adobe Connect in a browser.
  • Please contact info@sbiaevents.com for all technical questions.
  • If you encounter any technical issues before or during the event, please visit the Technical Issues Support page.
  • Test your PC for use with Adobe Connect prior to the day of the event. Adobe, the Adobe logo, Acrobat and Acrobat Connect are either registered trademarks or trademarks of Adobe Systems Incorporated in the United States and/or other countries.
Back to Top