Health ❯ Healthcare ❯ Regulation

FDA

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

8 ARTICLES

2w ago

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

Staff reviewers flagged poor human data plus safety and manufacturing gaps ahead of a July 23–24 advisory review that could shape access and enforcement

10 ARTICLES

4mo ago

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

4 ARTICLES

6mo ago

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

10 ARTICLES

6mo ago

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

4 ARTICLES

10mo ago

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

15 ARTICLES

11mo ago

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