Generic Drugs Forum (GDF) 2026 - 04/22/2026

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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

Continuing Education (CE)

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.

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

More Information

Food and 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 will be made when the order is picked up on site
  • Lunch selections must be made at time of registration. Changes cannot be accommodated after registration is complete
• 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.