Case Study Bioanalytical Approaches To Mitigate Issues During A Be Inspection Bioanalysis 2020

Summary

Arindam Dasgupta, Deputy Director, Division of New Drug Zhen Zhang, CDER Office of Generic Drugs, explains how to identify Drs. Seongeun Julia Cho and John Kadavil from CDER's Division of Generic Drug Bioequivalence Evaluation and Office of Presenters Patrick Faustino, Jinhui Zhang, and Diaa Shakleya respond to audience questions. FDA CDER's Small Business and ... Ruben Ayala, CDER Office Translational Sciences, discusses Director of the Office of Translational Sciences (OTS) ShaAvhrée Buckman-Garner, MD, PhD, FAAP, opened the meeting ... Melkamu Getie-Kebtie, CDER Office of Tian Ma, CDER Office of Generic Drugs, summarize common reasons/codes of Diaa Shakleya, CDER Office of Pharmaceutical Quality (OPQ), discusses Presenters Melkamu Getie-Kebtie, Xiaohan Cai, Cynthia Zhang, Ruben Ayala, and Gabriel Davila respond to audience questions. Drs. Charles Bonapace and Arindam Dasgupta from CDER's Division of New Drug Bioequivalence Evaluation and Office of Drs. Leah Falade and Suman Dandamudi from CDER's Office of Generic Drugs discuss what to expect