Generic Drugs Forum 2022 – Day 1, Session 2

Описание: FDA presents on the Current State of Generic Drugs and offers practical advice, presenting case studies, and taking a deep dive into the abbreviated new drug application assessment program. Presentations focus on topics such as the pre-ANDA program, generic drug metrics, post-market safety, pre-approval inspections, and global generic drug affairs. Includes Q&A session and a moderated panel discussion.


4:54 – ANDA Program Annual Public Stats and What they Mean: Office of Generic Drugs (OGD)
15:49 – ANDA Program Annual Public Stats and What they Mean: Office of Regulatory Operations (ORO)
35:07 - ANDA Program Annual Public Stats and What they Mean: Office of Generic Drug Policy (OGDP)
47:00 - ANDA Program Annual Public Stats and What they Mean: Office of Lifecycle Drug Products (OLDP)
56:22 – Questions & Panel Discussion

Presenters and Panel:

Iilun Murphy
Deputy Director, Clinical & Regulatory Affairs, OGD | CDER

Robert Berger - Analytics Team
David Holovac - Analytics Team
Russell Storms - Associate Director for Analytics
Edward (Ted) Sherwood – Director
ORO, OGD | CDER

Andrew Coogan
Lieutenant Commander, U.S. Public Health Service
Division of Legal and Regulatory Support (DLRS), OGDP | CDER

Derek Smith
Deputy Director, OPMA | Office of Pharmaceutical Quality (OPQ) | CDER

Geoffrey Wu
Commander, U.S. Public Health Service
Deputy Director, OLDP | OPQ | CDER

For slides and additional information: https://www.fda.gov/drugs/news-events...

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