Generic Drugs Forum (GDF) 2026:
April 22-23, 2026
View Start Time on World Clock
This is a NO COST event
FDA Headquarters – White Oak, Maryland
or attend Virtually Online
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.
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Agenda & Speaker Bios
Event Agenda
The event agenda is still being refined and will be linked here when it is ready.
Speaker Biographies
The speaker biographies document is under development and will be linked here when it is ready.
In-Person Attendance Information
Venue
FDA White Oak Campus
10903 New Hampshire Ave, Building 31
The Great Room
Silver Spring, MD 20903
Transportation & Parking
Food & Drink
- Public meeting attendees may bring their own food and drink as campus access is restricted to the immediate meeting area.
- For this event, light refreshments, sandwiches/wraps/salads are available for pre-order during the registration process. Payment is expected when the order is picked up on site.
- View Lunch Selections Available for Pre-Order
- Restaurants near the FDA White Oak campus are available. Before leaving, meeting attendees should consider the amount of time needed to return to campus and go through security screening.
Recording Disclosure
This event will be recorded and made available to the public after its conclusion. Any information shared publicly by participants during the event will become part of that recording. This includes the verbal questions and answers sessions.
For Reasonable Accommodations
If special accommodations at the workshop are needed due to a disability, please email CDERSBIA@fda.hhs.gov at least 7 days in advance of the workshop date. Requests for sign language interpretation or Computer Aided Realtime Translation (CART)/captioning should be made 2 weeks in advance of the workshop and should be sent directly to the FDA Interpreting Services Staff email account: interpreting.services@oc.fda.gov.
Virtual Attendance: LOGIN
The links below will become active on the day of the event.
The above rooms will open ~15 minutes before each day begins.
If you encounter any technical issues, visit the Technical Issues Support Page
Files & Recordings
Download Presentation Slides
The links above will become active on the day before the event begins.
Event Evaluation & Certificate
A link for you to evaluate the Event and access the online certificate will be added here on the second afternoon of the event.
Session Recordings
Recordings will be linked here as soon as they are available.
Questions & More Information
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 (until May 7, 2026).
This event 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.
Questions?
Please refer the FAQs page on this website. If you are not able to find your answer there, please email us at info@sbiaevents.com.
If you have questions regarding the content of the event or other CDER-specific information, please:
- Visit the CDER SBIA website
- Learn more about CDER SBIA Workshops and Webinars
- Subscribe to the CDER SBIA email updates
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