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Is FDA Going After RUO Diagnostics?

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Two SheppardMullin attorneys say it remains to be seen whether a recent FDA Warning Letter to DRG Instruments about selling resear...

FDA Halts Some Cell Clinical Trials

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FDA says it is reviewing all clinical trials that rely on a Biden administration exemption that allowed sensitive biological mater...

Top 2 FDA Cell/Gene Therapies Officials Pushed Out

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FDA places CBER Office of Therapeutic Products director Nicole Verdun and her deputy Rachael Anatol on administrative leave in the...

Securing Technology, Equipment Report

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The FDA Office of Regulatory and Emerging Science publishes a report describing agency efforts to research cybersecurity and advan...

FDA Warns on Transderm Scop Heat Complications

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FDA warns that Baxter Healthcares antinausea patch Transderm Scop (scopolamine transdermal system) can increase body temperature a...

DTC Ads Kennedys Next Target?

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Bloomberg News says President Trump and HHS secretary Kennedy are looking at policies that they hope would drive drug companies aw...

FDA Approves Gileads Yeztugo for HIV Prevention

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FDA approves Gileads Yeztugo as the only HIV pre-exposure prophylaxis twice-yearly option.

GDUFA Post-Warning Letter Meeting Guidance

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FDA publishes a guidance on its implementation of the post-Warning Letter meeting established in the GDUFA 3 commitment letter to ...

Open Bipartisan Probe of RFK Vaccine Plans: Pallone

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House Energy and Commerce Committee ranking Democrat Frank Pallone calls for a bipartisan committee investigation of HHS secretary...

CBERs Prasad Named Chief Medical/Scientific Officer

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CBER director Vinay Prasad has been appointed as FDAs chief medical and scientific officer, a new combination role for commissione...