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FDA

Peptides Gene Therapy Drug Approval Compounding Wellness Products Cosmetic Approvals Adverse Events Advisory Committees Drug Approval Process Cell and Gene Therapies Approval Process Clinical Guidelines Vaccine and Gene Therapy Product Quality Import Alerts

8 ARTICLES

last mo.

FDA Advisory Panel Narrowly Backs Compounding of Six Unapproved Peptides

The vote puts the FDA on a decision path that must reconcile agency scientists’ safety warnings with industry pressure before any change becomes legal.

8 ARTICLES

2mo ago

FDA Scientists Say Evidence Lacks for Allowing Seven Popular Peptides in Compounding

10 ARTICLES

6mo ago

FDA Proposes ‘Plausible Mechanism’ Pathway for Individualized Rare-Disease Therapies

4 ARTICLES

8mo ago

FDA Eases CMC Rules for Cell and Gene Therapies to Speed Development

10 ARTICLES

8mo ago

FDA Eases Oversight of Wearables and Clinical Decision Support in Final Guidance

4 ARTICLES

last yr.

FDA Creates 'Green List' for GLP-1 Ingredients as WHO Names the Drugs Essential

15 ARTICLES

last yr.

FDA Brings Back Vinay Prasad to Lead Biologics Unit After Brief Exit

3 ARTICLES

last yr.

FDA Investigates Fatal Liver Failures Linked to Sarepta’s Elevidys Therapy