News

FDA Names Former Pharmaceutical Executive To Oversee U.S. Drug Program
FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...
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 ...
BioSpace5d
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 ...
BioPharma Dive6d
Former biotech executive appointed to lead FDA drug office
George Tidmarsh, a Stanford University physician who founded Horizon Pharma and later ran La Jolla Pharma, was named head of ...
STAT7d
New head of FDA drug center is a biotech veteran and an outspoken critic of the academic establishment
“Dr. Tidmarsh is an accomplished physician-scientist and leader whose experience spans the full arc of drug development — ...
Opinion
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 unnecessary delays in the regulatory process.
Fierce Pharma7d
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 ...
PharmExec3d
Replimune CRL Fallout: How Biopharma Leaders Should Manage a New Layer of FDA Uncertainty
A deep dive into the implications of the Replimune CRL that surprised insiders and investors, the role of new leadership at ...
kcra.com1mon
FDA launches program for faster drug reviews - KCRA Channel 3
FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.