Media Summary: Markham C. Luke from CDER's Office of Generic Drugs discusses Myong-Jin Kim from CDER's Office of Generic Drugs discusses non- The purpose of this webinar was to provide current and prospective generic drug applicants insight on how PSGs are developed, ...
Product Specific Guidances For Complex - Detailed Analysis & Overview
Markham C. Luke from CDER's Office of Generic Drugs discusses Myong-Jin Kim from CDER's Office of Generic Drugs discusses non- The purpose of this webinar was to provide current and prospective generic drug applicants insight on how PSGs are developed, ... Mitchell Frost from CDER's Office of Generic Drugs discusses study population and terminology, bioequivalence studies with ... Dave Coppersmith and Myong-Jin Kim from CDER's Office of Generic Drugs provide information on Rob Lionberger, Lei Zhang, CDR Christine Le, Myong-Jin Kim, Markham Luke, Mitchell Frost, Paramjeet Kaur, David Coppersmith ...
Lei Zhang, Deputy Director of the Office of Research and Standards in FDA's Office of Generic Drugs, explains A presentation and panel discuss potential gaps in Presenters and presentations include: Advances in Iron Colloid Products: Denise Conti, CDER Office of Generic Drugs, provides an overview on orally inhaled and nasal drug
