Employees of companies regulated by the FDA—such as pharmas or biotechs—are no longer allowed to serve as members of FDA advisory committees, according to a new directive from the agency's ...
On April 17, 2025, FDA Commissioner Martin Makary announced a policy directive to limit industry representatives, who are employed by companies regulated by FDA from serving as official members on FDA ...
Recent comments from CDER Director George Tidmarsh suggesting that the agency may be backing away from the use of its independent expert panels for individual product approvals seem to be supported by ...
Alexander is a practicing internist and drug safety expert at the Johns Hopkins Bloomberg School of Public Health. Americans trust the Food and Drug Administration to make life-and-death decisions in ...
FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency’s decisions from ...
“What’s that? (I may be paranoid, but no android),” Radiohead once sang. That familiar tension between human judgment and technology echoes strong in today’s debate about artificial intelligence (“AI” ...
The recent controversies about the safety of antidepressants during pregnancy and hormone therapy for menopause were heightened by how decisions are being made. Earlier this month, HHS officials ...
FDA leaders under President Donald Trump are moving to abandon a decades-old policy of asking outside experts to review drug applications, a move critics say would shield the agency’s decisions from ...
On Tuesday, a U.S. Food and Drug Administration advisory committee voted unanimously that the oral formulation of a very common nasal decongestant, phenylephrine, is not effective. The decision could ...
MedPage Today on MSN
Five Leaders in One Year: FDA's Drug Center Enters 2026 at a Crossroads
The FDA appointed George Tidmarsh, MD, PhD, to be the nation's top drug official in July. The Center for Drug Evaluation and Research (CDER) has since cycled through another two leaders in 5 months.
Esteemed expert in the regulation and development of biopharmaceuticals, with more than three decades of experience spanning government, industry, and academia MIAMI, FL / ACCESS Newswire / August 21, ...
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