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Drug Shortages are National Security Risk: Califf

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FDA commissioner Robert Califf tells an Alliance for a Stronger FDA webinar that ongoing drug shortages are a huge national securi...

Oncologic Panel to Review Amgens Lumakras

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Federal Register notice: FDA announces a 10/5 Oncologic Drugs Advisory Committee meeting to discuss an Amgen supplemental NDA for ...

OTC Devices Dont Need Patient Self-Diagnosis: CHPA

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The Consumer Healthcare Product Association tells CDRH patient self-diagnosis need not be a requirement for the at-home use of ove...

FDA Approves Ingrezza for Huntingtons Chorea

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FDA approves a Neurocrine Biosciences NDA for Ingrezza (valbenazine) capsules for treating adults with chorea associated with Hunt...

FDA Partial Hold on Gileads Magrolimab

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FDA places a partial clinical hold on Gilead Sciences studies evaluating magrolimab to treat acute myeloid leukemia.

NDA for Myelodysplastic Syndromes Anemia

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FDA accepts for review a Geron NDA for imetelstat, a potential first-in-class telomerase inhibitor for treating transfusion-depend...

2 Drug Substance Nixed For Compounding

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Federal Register notice: FDA decides not to add ephedrine sulfate and hydroxychloroquine sulfate to its list of bulk drug substanc...

CDRH Strategic Group Org. Structure Correction

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Federal Register notice: FDA corrects an 8/14 notice that announced a modification to the organizational structure of CDRHs Office...

Drug Firms $300 Million Fine Over Price-Fixing

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The U.S. Justice Department fines Teva Pharmaceuticals USA and Glenmark Pharmaceuticals over $300 million in deferred prosecution ...

OPDP Cites Exeltis Promos on Social Media

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CDER Office of Prescription Drug Promotion cites Exeltis USA for making false or misleading claims in a social media post.