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Federal Register

Drug Supply Guidance Notice Corrected

Federal Register notice: FDA corrects a 3/10 notice on a draft guidance entitled Verification Systems Under the Drug Supply Chain Security Act for Cer...

Human Drugs

Evusheld Shows Neutralizing Activity Against Variants

New data from Washington University School of Medicine demonstrate that AstraZenecas Evusheld (tixagevimab co-packaged with cilgavimab) retains potent...

Human Drugs

Mercks Keytruda OKd in Endometrial Carcinoma

FDA approves Mercks Keytruda (pembrolizumab) for treating patients with advanced endometrial carcinoma that is microsatellite instability-high or mism...

Medical Devices

Saline Lock/Flush Syringes Shortage

FDA offers conservation strategies for healthcare professionals using prefilled 0.9% sodium chloride (saline) intravenous lock/flush syringes due to p...

Medical Devices

Class 1 Recall on Philips Respironics Ventilators

FDA classifies as Class 1 a Philips Respironics recall of certain V60 and V60 Plus ventilators because some of the devices had parts that were put tog...

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 3/18/2022.

Human Drugs

Product Approval Summaries

FDA Review posts product approval summaries for the week ending 3/18/2022.

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Human Drugs

Drug Industry Shrugs Off Accelerated Approval Reforms

PhRMA tells Congress that proposed reforms to the accelerated approval program are not needed and that it is concerned with any FDA-related policy pro...

Biologics

Moderna Seeks OK for Another Covid Booster Dose

Moderna submits an Emergency Use Authorization amendment to permit an additional Covid-19 vaccine booster (fourth dose) in adults 18 years of age and ...