Generic Drugs Forum 2022 – Day 1, Session 3

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.

0:05 – Culture of Quality
28:54– Data Integrity in ANDA Submissions
48:49 – Data Integrity Issues from BA/BE Clinical Site Inspections: Case Studies and OSIS Evaluation


Presenters and Panel:

Nilufer Tampal
Associate Director for Scientific Quality, Immediate Office | Office of Bioequivalence (OB) |Office of Generic Drugs (OGD) | CDER

Shujun Chen
Senior Pharmaceutical Quality Assessor, Division of Pharmaceutical Manufacturing II (DPMII), OPMA | Office of Pharmaceutical Quality (OPQ) | CDER

Minglei Cui
Commander, U.S. Public Health Service
Team Leader, Division of Bioequivalence II (DBII), OB | OGD | CDER

Cynthia (Yiyue) Zhang
Senior Staff Fellow, Division of New Drug Study Integrity (DNDSI), Office of Study Integrity and Surveillance Session (OSIS), Office of Translational Sciences (OTS) | CDER


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

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