News

FDA names former pharmaceutical company executive to oversee US drug program
FDA Commissioner Marty Makary announced that Dr. George Tidmarsh, a cancer and pediatric specialist, will direct the agency’s ...
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 ...
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 ...
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 ...
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 ...
PharmExec5d
FDA Appoints George Tidmarsh as Director of Center for Drug Evaluation and Research
Biotech veteran and Stanford physician-scientist brings 30 years of translational research and regulatory experience to ...
Seeking Alpha1mon
PharmaTher Applauds FDA's New Commissioner’s National Priority ...
The new CNPV program will allow drug developers to participate in a novel FDA priority program that significantly shortens the review time for a final drug application from approximately 10-12 ...
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 ...
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.