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Info Collection on Pharma Consensus Standards

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Federal Register notice: FDA sends to OMB a new information collection entitled Pharmaceutical Voluntary Consensus Standard Recogn...

Cassava Sciences Under Criminal Investigation: Reuters

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Reuters reports that the Department of Justice has opened a criminal investigation into Cassava Sciences over allegations it manip...

FDA OKs Bavarian Nordics Vaccine Facility

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FDA approves Bavarian Nordics fill and finish facility in Denmark to manufacture its Jynneos smallpox/monkeypox vaccine.

Non-Curative Setting Available Therapy

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FDA publishes a guidance with recommendations on including patients who have not received available therapy in non-curative settin...

Viz.ai Subdural Hemorrhage Detector Cleared

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FDA clears a Viz.ai 510(k) for its Viz Subdural (SDH), an algorithm that uses artificial intelligences to automatically detect sub...

Additional Benlysta Indication Approved

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FDA approves an additional indication for GlaxoSmithKlines Benlysta to treat children with active lupus nephritis who are receivin...

CGMP Violations in Bi-Coastal Pharma Inspection

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FDA warns Shrewsbury, NJ-based Bi-Coastal Pharma International about CGMP violations in its manufacturing of finished drugs.

API Deviations Found at Jost Chemical

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FDA warns St. Louis, MO-based Jost Chemical Co. about CGMP deviations in its production of active pharmaceutical ingredients.

Immuron Gut Drug on Clinical Hold

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FDA places a clinical hold on an unidentified Immuron investigational drug being evaluated for treating campylobacter and enteroto...

iRhythm AI ECG Algorithm Cleared for Zio Watch

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FDA clears an iRhythm Technologies 510(k) for its ZEUS (Zio ECG Utilization Software) System for the Zio Watch.