Article 15 Mar 2024 How To Run DMC? It's Tricky – FDA's New Draft Guidance Provides Updated Recommendations On How To Best Use Data Monitoring Committees In Clinical Trials United States Healthcare
Article 08 Mar 2024 FDA Flexes Its New FDORA Muscles In Withdrawing An Accelerated Approval United States Healthcare
Article 02 Jan 2024 FDA Announces A Return To In-Person Meetings For All PDUFA, BsUFA, And OMUFA Meeting Types 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 08 Nov 2023 FDA Denies Vanda's Citizen Petitions Regarding The Need For Braille Labeling For Tasimelteon Generics United States Healthcare
Article 08 Nov 2023 Welcome To SRP-RMT – Standardization Comes To Regenerative Medicine Therapies? United States Healthcare
Article 02 Nov 2023 FDA's New RWE Guidance Provides Recommendations For Sponsors Conducting Non-Interventional Real-World Studies And Describes The Potential To Use RWE For Initial Approvals In One Limited Circumstance United States Healthcare
Article 27 Oct 2023 FDA Brings Its Formal Meetings Guidance Up To Date: What You Need To Know About Type D, INTERACT, And "In-Person" Meetings Under PDUFA United States Healthcare