Product Specific Guidances Webinar Opening

Lei Zhang, Deputy Director of the Office of Research and Standards in FDA's Office of Generic Drugs, explains

The purpose of this

Rob Lionberger, Lei Zhang, CDR Christine Le, Myong-Jin Kim, Markham Luke, Mitchell Frost, Paramjeet Kaur, David Coppersmith ...

Mitchell Frost from CDER's Office of Generic Drugs discusses study population and terminology, bioequivalence studies with ...

This presentation provided an overview of the FDA

Dave Coppersmith and Myong-Jin Kim from CDER's Office of Generic Drugs provide information on

FDA presents updates on the Identification of Medicinal

Markham C. Luke from CDER's Office of Generic Drugs discusses

... Approaches for Topical Products – Part II 44:33 – An Overview of the Current

The Competition and Consumer Commission of Singapore (CCCS) has published the

Director of the Office of Research and Standards (ORS) Robert Lionberger in the Office of Generic Drugs at CDER provides ...

FDA experts demonstrate the FDA's Generic Drug User Fee Amendments (GDUFA) Science and Research Program's ...

Lanyan (Lucy) Fang, PhD-FDA Gabriel Innes, VMD, PhD-FDA Luis Pinheiro, PharmD, MEpi-European Medicines Agency Robert ...

This presentation provided an overview of the U.S FDA PSG program, including how and when PSGs are published, navigating ...

This presentation described how ongoing research contributes to the evolution of

FDA experts demonstrate the FDA's Generic Drug User Fee Amendments (GDUFA) Science and Research Program's ...

On September 9, 2022, the U.S. Food and Drug Administration (FDA) hosted a

Note: This is the replay of a