Charles G. Raver

When Is A Confirmatory Trial "Underway" Or Conducted With "Due Diligence" Enough For Accelerated Approval? FDA Explains Its New Authorities

FDA Issues Draft Guidance On Accelerated Approval: A Substantial Evidentiary And Procedural Overhaul To This High-Profile Pathway

FDA Issues "Cliffs Notes"-Style Guidance On Cell And Gene Therapy; What Questions Did They Answer? (Part 1)

FDA Creates A New Advisory Committee For Genetic Metabolic Diseases – Could This Be An Opportunity To Support Rare Disease Product Development More Broadly?

Long-Awaited Guidance On FDAMA 115: Confirmatory Evidence Finally Has Its Moment (To Be Crossed Off The FDA's Guidance To-Do List)