Advancing Generic Drug Development: Translating Science to Approval 2025

Events / Workshops / Webinars
1

Date:
October 7 - 8, 2025

Day1:
Tue, Oct 07 9:00 a.m. - 04:00 p.m. ET

Day2:
Wed, Oct 08 9:00 a.m. - 03:00 p.m. ET

Organized By:
Office of Generic Drugs

Advancing Generic Drug Development: Translating Science to Approval 2025 - 10/07/2025 | FDA

Event Details

Join us for the 2025 Advancing Generic Drug Development Workshop! FDA experts will demonstrate the FDA’s Generic Drug User Fee Amendments (GDUFA) Science and Research Program’s transformative impact on generic drug development, regulation, and approval. Dissect complex scientific challenges in abbreviated new drug applications (ANDAs) alongside FDA experts, and gain insights into GDUFA III progress, GDUFA science and research on complex products and scientific issues related to product-specific guidance development, as well as pre-ANDA and ANDA meeting discussions. The workshop will also highlight innovative science and cutting-edge methodologies in generic drug development.

image
image542×783 106 KB

4 Likes
2

Thank you for the opportunity to research and share some of the views of scientists and specialists in the field of branched-chain nitrosamines.

Please share the link with the attendees and prepare some important points for the attendees.

1 Like
3

Dear colleagues,

I’m eager to hear your perspectives on the event that took place yesterday. From my point of view, the FDA addressed several important topics that are currently being discussed in other posts here, especially highlighting key points regarding the establishment of limits.

Looking forward to your insights and thoughts.

Best regards,
Joao Gerheim

1 Like
4

FDA Advancing Generic Drugs 2025:

Nitrosamine Impacted Drugs Containing BCS IV Drug Substances

Potential Pitfalls in Nitrosamine Risk Assessment and Control

Pharm/Tox for the Safety Evaluation of Nitrosamine Impurities

Session 4: Q&A Panel and Day Two Closing

4 Likes