News

BioSpace5h
From Expertise to Empty Chairs: The FDA’s Self-Inflicted Crisis
While FDA Commissioner Marty Makary emphasizes learning and humility, the FDA has systematically removed the very experience ...
FDA Commissioner: 100 Days of Change—Modernizing the FDA for a Healthier America | Opinion
The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and ...
Fierce Pharma2d
FDA names next CDER director in biotech vet George Tidmarsh
FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and ...
BioSpace10h
FDA Opens Pilot Run of Commissioner Voucher Program
The FDA will select at most five companies that align with national priorities, including lower drug prices and increased ...
FDA’s artificial intelligence is supposed to revolutionize drug approvals. It’s making up studies
Insiders tell CNN the FDA’s AI is “hallucinating” studies and can’t access key documents. Agency leaders insist the AI is getting better, and use is not mandatory.
Benzinga.com2mon
New FDA Leadership Could Raise The Bar For Drug Approvals
New FDA Leadership Team: The FDA's top leadership has shifted under Commissioner Dr. Marty Makary, ... signals potential changes in FDA priorities and how the agency engages with biotech ...
FDA Rejects Replimune’s Skin Cancer Treatment, Shares Sink
Replimune Group Inc. shares sank to their lowest point ever after US regulators rejected a skin cancer treatment from the ...
KGW83mon
FDA tobacco regulator ousted as health agency shakes up leadership ...
The leadership vacuum comes as Kennedy moves to fire 3,500 FDA staffers and pushes ahead with plans to scrutinize ultra-processed foods, childhood vaccines, antidepressants and other long ...