News

MedPage Today on MSN19hOpinion
How Fast Is Too Fast for FDA Drug Review?
In announcing his new Commissioner's National Priority Voucher (CNPV) program, FDA Commissioner Marty Makary, MD, MPH, ...
Fierce Biotech7d
Marty Makary talks DOGE cuts, new voucher program and why FDA still 'on track' to meet all PDUFA dates
All the figurative FDA trains are running on time, according to the agency’s leader Marty Makary, M.D. | “I'm proud to report ...
FDA's Makary sought to reject KalVista’s drug: report
FDA Commissioner Marty Makary reportedly initiated a brief request last week to decline approval of a rare disease drug ...
BioSpace1d
FDA Conditional Pathway Not Necessary, Rare Disease Experts Say, While Applauding Intent
Speaking at BIO2025, rare disease leaders from Ultragenyx, Amylyx and Yale questioned the need for the new regulatory pathway ...
New FDA Chief Wants to Fast-Track Some Drugs, Use More AI
FDA Commissioner Marty Makary faces declining staff morale as he remakes the agency.
FDA to offer faster drug reviews to companies promoting ‘national priorities’
The Food and Drug Administration says it will begin offering faster reviews to new medicines that align with Trump ...
BioSpace6d
Makary Doubles Down on Push To ‘Modernize’ FDA, Eyes Speedier Reviews
Speaking at BIO 2025, Makary bemoaned what he called “unnecessary steps” and “avoidable delays” in the U.S. regulatory ...
STAT2d
FDA chief’s goals of ‘radical transparency’ threatened by agency cuts
But current and former agency staff, as well as medical ethics experts, say recent cuts at the FDA are already making it more ...
FDA chief wary of federal recommendations for Covid-19 vaccines
The Food and Drug Administration commissioner repeatedly said patients should rely on guidance from their doctors.
FDA announces sweeping changes to speed up the drug review process
An FDA pilot program, known as the Commissioner’s Priority Voucher program, could drastically change the way pharmaceutical ...
Wall Street Journal8d
New FDA Chief Marty Makary Wants to Fast-Track Some Drugs, Use More AI - WSJ - The Wall Street Journal
Marty Makary’s stewardship of the FDA will be key to the policy success of the Make America Healthy Again movement. Photo: drew angerer/Agence France-Presse/Getty Images ...