Generic Drugs Forum 2025 – Hosted by FDA SBIA

The Generic Drugs Forum is an annual, two-day event that offers attendees the opportunity to hear from FDA subject matter experts from every part of the generic drug assessment program. The goal of the forum is to provide information to aid potential and current applicants by offering practical advice and taking a deep dive into the Abbreviated New Drug Application (ANDA) assessment process.

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

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.