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RFK Jr. Ignores Hill Request on Anti-Vax Activist HHS Role

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HHS secretary Robert F. Kennedy Jr. faces renewed scrutiny from Senate Democrats for ignoring requests about the role of longtime ...

Lilly Says Retatrutide Delivered Up to 30% Weight Loss

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Eli Lilly reports that its investigational obesity drug retatrutide produced weight-loss results approaching those historically as...

All India Institute Clinical Trial Issues

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FDA warns Dr. Sourav Mishra about violations in his conduct of a clinical investigation at the All India Institute of Medical Scie...

Naseem Jaffrani BIMO Violation

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FDA warns Alexandria, LA-based cardiologist Naseem Jaffrani about his failure to conduct a clinical investigation according to the...

Will the Next Commissioner Learn from Makarys Mistakes?

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Former FDA associate commissioner Peter Pitts says FDA has an opportunity with the resignation of commissioner Marty Makary to res...

FDA Has to Build CRISPR Edit Review Protocol

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A Clinical Trial Vanguard post describes the issues facing FDA in determining how to review and approve a BLA for a one-time CRISP...

Guidance on Drug Food Effects Studies

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FDA publishes a guidance with recommendations for sponsors planning to submit food-effect studies for INDs or NDAs.

Bipartisan Bill to Lower Rx Drug Costs

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Reps. Eric Sorensen and Stephanie Bice introduce bipartisan legislation to allow FDA to deny so-called sham citizen petitions file...

Implantica Submits Final FDA Response for RefluxStop PMA

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Implantica files the final response to FDA on its PMA for RefluxStop that addresses the agencys remaining questions tied to Module...

Valar Labs Wins Breakthrough Status for AI Bladder Cancer Test

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FDA grants Valar Labs a breakthrough device designation for its Vesta Bladder Risk Stratify Dx test.