Product Specific Guidance Fundamentals From A Clinical Perspective

Summary

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 On June 3, 2026, FDA published a Christine Le from CDER's Office of Generic Drugs discusses the Rob Lionberger, Lei Zhang, CDR Christine Le, Myong-Jin Kim, Markham Luke, Mitchell Frost, Paramjeet Kaur, David Coppersmith ... Want to find out more about the The purpose of this webinar was to provide current and prospective generic drug applicants insight on how PSGs are developed, ... Lei Zhang, Deputy Director of the Office of Research and Standards in FDA's Office of Generic Drugs, explains Markham C. Luke from CDER's Office of Generic Drugs discusses Dave Coppersmith and Myong-Jin Kim from CDER's Office of Generic Drugs provide information on On July 25, 2022, FDA hosted a public meeting titled “Using Methods from PFDD This presentation discussed in silico methodologies for topical Eleftheria Tsakalozou from the Office of Generic Drugs illustrates how modeling and simulation approaches such as ...