Generic Drugs Forum 2022 – Day 1, Session 1

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.

0.01 – Keynote
12.01 – Office of Generic Drugs Keynote
18:45 – Office of Pharmaceutical Quality Keynote
41:17 – Use of Knowledge-Aided Assessment and Structured Application (KASA) in Drug Product Assessment
1:03:16 - Use of Knowledge-Aided Assessment and Structured Application (KASA) in Drug Product Manufacturing Assessment
1:21:07 - Use of Knowledge-Aided Assessment and Structured Application (KASA) in Biopharmaceutics Assessment
1:40:57 – Integrated Drug Product Assessment: Expectations
2:01:32 – Questions & Panel Discussion


Presenters and Panel:

Janet Woodcock
Principal Deputy Commissioner, Office of the Commissioner, FDA

Sally Choe
Director, Office of Generic Drugs (OGD) | CDER

Michael Kopcha
Director, Office of Pharmaceutical Quality (OPQ) | CDER

Peter Capella
Director, Division of Immediate and Modified Release Products II (DIMRPII), Office of Life Cycle Products (OLDP) |OPQ | CDER

Rakhi Shah
Associate Director, Office of Pharmaceutical Manufacturing Assessment (OPMA) | OPQ | CDER

Kimberly Raines
Branch Chief, Division of Biopharmaceutics, Office of New Drug Products (ONDP) | OPQ | CDER

Mayra Pineiro Sanchez
Senior Pharmaceutical Quality Assessor, Division of Immediate and Modified Release Products II, OLDP | OPQ | CDER

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

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