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FDA Press Conference

Today at 1:30 p.m. EDT, watch FDA Commissioner Makary unveil the agency's real-time clinical trials initiative—a major step to accelerate cures for patients.

Watch the press conference
Dr. Makary photo

1 Year of Reforms
 
 
  • Fixing warnings on HRT
  • Initiated national priority vouchers
  • Accelerating biosimilars
  • Boosting domestic manufacturing
  • Modernizing infant formula
  • Removing artificial food dyes
  • Approving natural food dyes
  • Unleashing cell & gene therapies
  • Seizing illegal vapes
  • Fixing opioid labels
  • Cracking down on pharma ads
  • Reducing animal testing
  • Launching new dietary guidelines
  • Revised Covid-19 vax framework
  • Published FDA rejection letters
  • Reviewing chemicals in food
  • Closing GRAS loophole
  • Launched FDA Direct Podcast
  • Ending war on natural fats
  • Hosted CEO listening tour
  • Took action on 7-OH opioids
  • Launched Elsa AI tool
  • Defining ultra-processed foods
  • Fixing orange juice regs
  • Launched Agentic AI tool

And we're just getting started...

Featured Topics

Recalls
Report a Problem
Warning Letters
Consumer Updates
483s
EUAs
510Ks
Guidance Documents
Drug Databases
Import Program

FDA in Action

FDA Achieves Year 1 Goals in Reducing Animal Testing in Drug Development
FDA takes action to advance gene therapy development
FDA Voices: FDA Scientists Working in Satellite Laboratories Across U.S. Help Prevent Harmful Drugs from Reaching Americans
FDA launches cost-saving single platform for Adverse Event reporting
FDA releases guidance on Plausible Mechanism Framework
FDA PreCheck Pilot Program Strengthens Domestic Pharmaceutical Manufacturing
FDA Grant Two Petitions to Expand Food Color Options
FDA approves first-ever gene therapy for treatment of genetic hearing loss

Press Announcements

April 24, 2026

FDA Accelerates Action on Treatments for Serious Mental Illness Following Executive Order

April 23, 2026

FDA Approves First-Ever Gene Therapy for Treatment of Genetic Hearing Loss Under National Priority Voucher Program

April 23, 2026

CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices

Products We Regulate

Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood, and Biologics
Animal and Veterinary
Cosmetics
Tobacco Products
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