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Many Deficiencies in Musk Neuralink Brain Chip: FDA

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A Reuters investigative report relying on anonymous sources says FDA has rejected an application from Elon Musks Neuralink to open...

Bill to Restrict REMS from Delaying Competition

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A Senate bipartisan bill aims to close a loophole that pharmaceutical companies can exploit to block drug competition, including g...

FDA, Expert Debate Bivalent Covid Vaccine Deployment

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FDA commissioner Robert Califf, CBER director Peter Marks, and Childrens Hospital of Philadelphia vaccine expert Paul Offit debate...

Office of Generic Drugs 2022 Highlights

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The CDER Office of Generic Drugs annual report says it approved 914 new ANDAs in 2022 and took many other steps under the GDUFA 3 ...

Q13 Drug Continuous Manufacturing Guidance

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FDA publishes the International Council on Harmonization Q13 guidance on continuous manufacturing of drug substances and products.

FDA Mulls Artificial Intelligence Use in Drug Manufacturing

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FDA outlines new potential GMP issues under policy consideration in a discussion paper entitled Artificial Intelligence (AI) in Dr...

Government Wins $43 Million Verdict in Kickback Case

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A jury returns a $43 million verdict against Precision Lens for violations of the False Claims Act and Anti-Kickback Statute.

Multiple Violations Seen in Skyless Inspection

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FDA warns Ponce, Puerto Rico-based Skyless LLC about CGMP, new drug, misbranding, and other violations in its production of drug p...

Monoclonal Antibody Potency Assay Guidance

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FDA publishes a draft guidance with recommendations on assessing the potency of monoclonal antibodies and some other therapeutic p...

FDA Highlights Rare Disease Day 2023 with ARC

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CDER associate director for rare diseases Kerry Jo Lee marks Rare Disease Day 2023 by highlighting the new Accelerate Rare disease...