James E. Valentine

Where Does Rare Disease And Patient-Focus Fall Into Commissioner Makary's Priorities & The MAHA Platform For FDA? A New Ultrarare Approval Pathway & More

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FDA Issues Draft Guidance On Accelerated Approval: A Substantial Evidentiary And Procedural Overhaul To This High-Profile Pathway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 CMC Questions Did They Answer? (Part 2)

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

Regulator And Funder? FDA's Orphan Products Grants Program Awards Significant Funding To Help Move Promising Treatments Through Clinical Development

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

FDA Brings Its Formal Meetings Guidance Up To Date: What You Need To Know About Type D, INTERACT, And "In-Person" Meetings Under PDUFA

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

FDA Moves Beyond COVID-19, But Impacts On COVID-19 Era Clinical Trials Remain