Back to: FDA Draft ICH M13B Additional Strengths Biowaiver Guideline Webinar
Presenters:
Joseph Kotsybar, PharmD
Project Manager
Office of Research and Standard (ORS) | Office of Generic Drugs (OGD)
Center for Drug Evaluation and Research (CDER), FDA
Lei Zhang, PhD
Deputy Director
Office of Research and Standards (ORS) | OGD | CDER | FDA
Nilufer Tampal, PhD
Associate Director of Scientific Quality
Office of Bioequivalence (OB) | OGD | CDER | FDA
Kimberly Raines, PhD
Associate Director of Science
Office of Policy for Pharmaceutical Quality
Office of Pharmaceutical Quality (OPQ) | CDER | FDA