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FDA Generic Drugs Forum 2026

Generic Drugs Forum (GDF) 2026:
April 22-23, 2026

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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Event Agenda

The event agenda is still being refined and may be updated over time. The current version is v10, uploaded on April 15, 2026.

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Speaker Biographies

The speaker biographies document provides detailed information for each of the event presenters.