Mark A. Tobolowsky

FDA Begins Granting Advanced Manufacturing Technology Designations

FDA Appears To Be Granting Zombie Rare Pediatric Disease Designations Waiting For The Rare Pediatric Disease Priority Review Voucher Program To Be Revived

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

The Sun Has Started To Set On The Rare Pediatric Disease Priority Review Voucher Program – But It Can Still Be Saved

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

FDA Guidance Outlines A Framework For The Evaluation Of Long-Term Neurodevelopmental Safety Studies In Neonatal Product Development

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 It's Tricky – FDA's New Draft Guidance Provides Updated Recommendations On How To Best Use Data Monitoring Committees In Clinical Trials

FDA Flexes Its New FDORA Muscles In Withdrawing An Accelerated Approval

FDA Announces A Return To In-Person Meetings For All PDUFA, BsUFA, And OMUFA Meeting Types

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