Article 05 Feb 2025 When Is A Confirmatory Trial "Underway" Or Conducted With "Due Diligence" Enough For Accelerated Approval? FDA Explains Its New Authorities United States Healthcare
Article 15 Jan 2025 FDA Issues Draft Guidance On Accelerated Approval: A Substantial Evidentiary And Procedural Overhaul To This High-Profile Pathway United States Healthcare
Article 10 Dec 2024 FDA Issues "Cliffs Notes"-Style Guidance On Cell And Gene Therapy; What Questions Did They Answer? (Part 1) United States Healthcare
Article 20 Dec 2023 FDA Creates A New Advisory Committee For Genetic Metabolic Diseases – Could This Be An Opportunity To Support Rare Disease Product Development More Broadly? United States Healthcare
Article 27 Oct 2023 Long-Awaited Guidance On FDAMA 115: Confirmatory Evidence Finally Has Its Moment (To Be Crossed Off The FDA's Guidance To-Do List) United States Healthcare