News Vinay Prasad returns to FDA In a new spin on the concept of the FDA's 'revolving door', Vinay Prasad is back as head of CBER, just over a week after leaving the role.
News Medical groups sue RFK Jr over COVID-19 policies Medical groups have sued HHS Secretary Robert F Kennedy Jr for removing healthy children and pregnant women from COVID-19 shot recommendations.
Patients BIO 2025: Planning, not panic, as BIO weighs in on US vaccin... At BIO 2025, vaccines were top of mind as a result of recent actions by HHS. Speakers addressed news head on, but also explored the larger context.
Market Access BIO 2025: Makary: Drugs don’t have to take 10 years to get t... FDA Commissioner Dr Martin Makary took the stage at BIO 2025 to detail the way he and his team have been challenging “deeply held assumptions”.
News Amid staff cuts, FDA looks to AI to 'optimise' reviews The FDA has rolled out its highly-touted generative AI tool, almost a month early, with a promise to reduce the time taken for regulatory reviews.
News FDA announces generative AI pilot and rapid rollout plans The FDA has completed a pilot of a new GenAI technology for speeding up drug reviews– And it wants to move from pilot to implementation in two months
News US launches probe of German 'underpayment' for medicines A Section 301 probe by the US Trade Representative into Germany's medicine pricing and reimbursement policies raises the threat of punitive tariffs.
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