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Federal Register

Guide on Drug Dosage and Administration Labeling

Federal Register notice: FDA posts a draft guidance entitled Dosage and Administration Section of Labeling for Human Prescription Drug and Biological ...

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Federal Register

Digital Sleep Disturbance Devices are Class 2

Federal Register notice: FDA classifies digital therapy devices used to reduce sleep disturbance for psychiatric conditions into Class 2.

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Medical Devices

Coviden Recalls Mahurkar Dialysis Catheter

Medtronics Coviden unit recalls its Mahurkar 13.5Fr high-flow, dual lumen acute dialysis catheter based on a potential leaking condition within the hu...

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Human Drugs

Novo Nordisks Rebelsus Now OK for 1st Line Use

FDA approves a Novo Nordisk label update for Rybelsus (semaglutide) tablets 7 mg or 14 mg for a first-line treatment option for adults with Type 2 dia...

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Medical Devices

Man Pleads Guilty to Selling Used Medical Devices

Kambiz Youabian (Tarzana, CA) pleads guilty to a two-count information charging him with mail fraud and introducing misbranded medical devices into in...

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Human Drugs

5 Observations in Alembic FDA Inspection

Indias BQ Prime financial news platform discloses five observations from an FDA inspection at an Alembic Pharmaceuticals non-sterile drug manufacturin...

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Biologics

Stop Trying to Prevent Covid in Healthy People: Offit

FDA vaccines advisory committee member Paul Offit says the U.S. should stop trying to prevent symptomatic Covid infections in healthy young people by ...

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Human Drugs

Dosage and Administration Label Section Guidance

FDA publishes a guidance to help applicants prepare the Dosage and Administration section of labeling for prescription drug and biological products.

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Medical Devices

Minor Updates to 2 Covid Test Guidances

FDA announces updates to two Covid-19 testing guidances.

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Human Drugs

Qualigen Therapeutics Gains Orphan Drug Designation

FDA grants Qualigen Therapeutics an orphan drug designation for QN-302 and its use in treating pancreatic cancer.