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Medical Devices

CDRH OKd 19 Breakthrough Devices in 2022

The CDRH 2022 annual report says the Center responded to many unique and important issues.

Human Drugs

AstraZenecas Evusheld No Longer OK for Emergency Use

FDA says AstraZenecas Evusheld is no longer authorized for emergency use to fight Covid-19 infections.

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Human Drugs

Emergent Recalls Skin Decontamination Lotion

Emergent recalls certain Reactive Skin Decontamination Lotion kits from a specific batch based on customer complaints about leakages.

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Medical Devices

Dental Practices Defrauded FDA: Justice Dept.

The U.S. Justice Department charges 12 dental practice owners and co-conspirators with defrauding FDA, Medicaid, U.S. Immigration authorities, and the...

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Human Drugs

Torrent Inspection Classified as Official Action Indicated

FDA tells Torrent Pharmaceuticals that a 9/2022 inspection of the companys India (Indrad, Gujarat) facility has been classified as Official Action Ind...

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Human Drugs

No Evidence of Contaminated Cough Syrup in U.S.: FDA

FDA says there is no evidence that contaminated cough syrups that have killed children in Asia and Africa have entered the U.S. supply chain.

Biologics

Panel Backs Plan to Harmonize Covid Vaccine Composition

FDAs Vaccines and Related Biological Products Advisory Committee unanimously votes (21 to 0) to recommend that Covid-19 vaccine composition be harmoni...

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Human Drugs

Ex-Pharma Sales Rep Debarred Over Juxtepid Prescriptions

FDA permanently debars former Aegerion Pharmaceuticals sales representative Mark Moffett for his role in padding his sales bonuses by persuading physi...

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Federal Register

Final Guide on Compounding Ibuprofen Suspensions

Federal Register notice: FDA releases a final guidance entitled Compounding Certain Ibuprofen Oral Suspension Products Under Section 503B of the Feder...

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Medical Devices

Cardiosave Intra-Aortic Balloon Pumps Recalled

Datascope/Getinge recalls its Cardiosave Hybrid and Rescue Intra-Aortic Balloon Pumps due to the risk of blood entering the devices through a damaged ...