Bruce Palsulich

Mar 10, 2023 | clinicalleader.com | Mark Durivage |Bruce Palsulich |Gary Shorter |Pankaj Manon

New FDA Draft Guidance Addresses Data Considerations For Externally Controlled Trials   Guest Column | By Mark Durivage, Quality Systems Compliance LLC   The FDA recently released for public comment Considerations for the Design and Conduct of Externally Controlled Trials for Drug and Biological Products.