Back to: FDA Draft ICH M13B Additional Strengths Biowaiver Guideline Webinar
Moderator:
Sarah A. Ibrahim, PhD
Associate Director for Stakeholder and Global Engagement
OGD | CDER | FDA
Panelists:
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
David Coppersmith, JD
Regulatory Counsel
Division of Policy Development (DPD)
Office of Generic Drug Policy (OGDP) | OGD | CDER | FDA
Robert Lionberger, PhD
Director
ORS | OGD | CDER | FDA
Bhagwant Rege, PhD
Division Director
Office of Pharmaceutical Quality Assessment I | OPQ | CDER | FDA
Partha Roy, PhD
Director
OB | OGD | CDER | FDA