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PharmExec42m
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 ...
100 days into the job, FDA head talks to CNN about agency goals— and Coke’s switch to sugar
Commissioner Marty Makary says the FDA will plow ahead with big plans on ultra process foods, dietary guidelines and ...
Filter1dOpinion
Confirmation of Trump’s DEA Pick Will Bring More of the Same, or Worse
Terrance Cole is seen as a status quo appointment that will oppose reform, and could empower the administration's "war with ...
BioSpace1d
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 ...
BioSpace2d
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 ...
Modern Retina3d
Ocugen announces new SAB members and leadership changes
Modern Retina provides ophthalmology professionals with the latest advancements, research, and expert insights in retinal ...
The Northwest Arkansas Democrat-Gazette3d
FDA taps new leader for drug program
The Food and Drug Administration on Monday named a longtime pharmaceutical executive to run the agency's drug program, the latest in a string of leadership changes at the agency.
Fierce Pharma4d
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 ...
JD Supra1mon
Staying Prepared Amid FDA Changes | Gardner Law - JDSupra
Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers should not interpret these changes as a signal of reduced regulatory ...