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Human Drugs

Bill to Restrict REMS from Delaying Competition

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

Biologics

FDA, Expert Debate Bivalent Covid Vaccine Deployment

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

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Human Drugs

Panel Meeting Nixed on OTC Opioid Reversal Agent

Federal Register notice: FDA cancels for undisclosed reasons a 3/20 joint meeting of the Nonprescription Drugs Advisory Committee and Anesthetic and A...

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Human Drugs

FDA Clears Bigfoot Bio Android Diabetes App

FDA clears a Bigfoot Biomedical 510(k) for the Android version of the Bigfoot Unity Mobile App, which is a part of the Bigfoot Unity Diabetes Manageme...

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Medical Devices

Noah Medicals Robotic Bronchoscopy Device Cleared

FDA clears a Noah Medical 510(k) for the Galaxy System, a robotic-navigated bronchoscopy device and accessories that are intended to provide bronchosc...

Human Drugs

Office of Generic Drugs 2022 Highlights

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 reauthorization.

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Human Drugs

Q13 Drug Continuous Manufacturing Guidance

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

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Human Drugs

FDA Mulls Artificial Intelligence Use in Drug Manufacturing

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

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Human Drugs

Government Wins $43 Million Verdict in Kickback Case

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

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Human Drugs

Multiple Violations Seen in Skyless Inspection

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