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Human Drugs

Hospira Recalls Injectable Vancomycin Due to Particulates

Hospira recalls one lot of injectable vancomycin HCl single-dose fliptop 1.5 g vials due to two visible glass particulates observed in a single vial.

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Federal Register

FDA Publishes 5 Device Classification Notices

FDA posts five device classifications that were requested under the agencys de novo program.

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Medical Devices

Law Extends Product Info Sharing Safe Harbor to Devices

The recent omnibus legislation extends a drug company safe harbor to medical device companies on sharing health care economic information, according t...

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Biologics

Evusheld May Not Neutralize New Covid Variant: FDA

An FDA update says AstraZenecas Evusheld may not neutralize the new Covid-19 variant XBB.1.5.

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Human Drugs

FDA Delays Toripalimab PDUFA Action Date

FDA delays the PDUFA action date for Junshi Biosciences toripalimab because Covid travel restrictions involving China are preventing a needed facility...

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Human Drugs

FDA Hits Ipsen with Complete Response on Palovarotene

FDA issues Ipsen Biopharmaceuticals a complete response letter on its NDA for palovarotene, an investigational treatment for reducing new abnormal bon...

Human Drugs

Generic Drug Controlled Correspondence Revised Guidance

FDA publishes a draft guidance updating with GDUFA 3 commitments a 2020 guidance on generic drug development controlled correspondence.

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FDA General

ODT Launches Leadership Modernization Action Plan

FDA launches a digital technology Leadership Modernization Action Plan.

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Human Drugs

5 Observations on Glenmark FDA-483

FDA releases the form FDA-483 issued following an inspection at the Goa, India-based Glenmark Pharmaceuticals drug manufacturing facility.

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FDA Approves Rozlytrek Companion Diagnostic

FDA approves a Foundation Medicine blood-based companion diagnostic for Genentechs cancer drug Rozlytrek.