Here's How Trump's Pick To Lead The FDA Can Supercharge The Agency
The U.S. Senate last week confirmed former Johns Hopkins surgeon and professor Dr. Marty Makary to lead the Food and Drug ...
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FDA staff cuts could disrupt drug reviews, putting agency's critical funding programs at risk: reports
Massive cuts at the FDA have hit staff tied to drug reviews and user fees, putting future approvals in jeopardy, according to ...
Compound versions of some weight loss drugs to be restricted
Zepbound contains the same active ingredient, tirzepatide, as Mounjaro, which is also made by Lilly and is FDA-approved to ...
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How consultants help accelerate drug product development timelines
Leveraging FDA Fast Track and Accelerated Approval pathways Consultants can reduce drug development timelines by leveraging ... streamlining the regulatory process. Engagement with Contract ...
Axios on MSN3d
Drug industry worries about FDA delays
Pharmaceutical companies are growing increasingly concerned widespread cuts at the Food and Drug Administration could set the ...
FDA delays full approval of Novavax Covid-19 vaccine even though it was on track for clearance
The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on ...
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FDA’s New Accelerated Approval Draft Guidance
The FDA’s latest ... Accelerated Approval of Drugs and Biologics,” is a game-changer for biopharmaceutical companies hoping to bring life-saving treatments to market. If you’re navigating the ...
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Federal judge blocks FDA's regulation of lab-developed tests
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses ...
US drug regulator delays Novavax COVID vaccine approval
The US drug regulator has missed a deadline for granting full approval to Novavax's COVID-19 vaccine, the company said ...
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FDA delays full approval of Novavax COVID-19 vaccine even though it was on track for clearance
The U.S. Food and Drug Administration has delayed granting full approval of Novavax's ... A spokesman for HHS told CNN, "The FDA's independent review process for the Novavax vaccine, like all ...