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FDA WEBVIEW CLOSED 6/19 FOR JUNETEENTH

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FDA Webviews newsroom closes Wednesday 6/19 in recognition of the federal holiday Juneteenth.

Medical Gas GMP, Safety Reporting Rule

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Federal Register notice: FDA issues a final rule revising its requirements for current good manufacturing practice, postmarketing ...

Clinical Hold on Zentalis Drug After 2 Deaths

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FDA places a partial clinical hold on three Zentalis Pharmaceuticals azenosertib studies after two recent deaths due to presumed s...

Elixir Breakthrough Status for Coronary Bioadapter

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FDA grants Elixir Medical a Breakthrough Device Designation for its novel bioadaptive implant DynamX Sirolimus-Eluting Coronary Bi...

Mercks Pneumococcal 21-Valent Vaccine Approved

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FDA grants Merck accelerated approval for Capvaxive (Pneumococcal 21-valent conjugate vaccine) for preventing invasive disease and...

Akili OTC App Cleared for ADHD

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FDA clears an Akili 510(k) for EndeavorOTC (AKL-T01) as an over-the-counter treatment for adults with attention-deficit/hyperactiv...

Draft Guide on Vet Safety Studies: Correction

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Federal Register notice: FDA corrects a 5/23 notice announcing the availability of a draft revised guidance #115 (VICH GL22) entit...

QA Practice for AI Devices is Priority: FDA

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CDRH Digital Health Center of Excellence director Troy Tazbaz says that developing a medical device quality assurance practice for...

Guide on Oligonucleotide Clin/Pharm Considerations

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Federal Register notice: FDA makes available a final guidance entitled Clinical Pharmacology Considerations for the Development of...

Takeda Soticlestat Studies Miss Primary Endpoints

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Takeda says data from its SKYLINE and SKYWAY studies of soticlestat (TAK-935) in Dravet syndrome and Lennox-Gastaut syndrome patie...