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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.

FDA Approves Guardant Healths Next-Generation Guardant360 Liquid CDx

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FDA approves Guardant Healths next-generation Guardant360 Liquid CDx, a blood-based comprehensive genomic profiling test designed ...

ImmunityBios Anktiva sBLA for Expanded Use Accepted by FDA

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FDA accepts for review an ImmunityBio supplemental BLA seeking to expand the label for Anktiva (nogapendekin alfa inbakicept-pmln)...