FDA Related News

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.

Federal Register

FDA Publishes 5 Device Classification Notices

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

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...

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.

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...

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FDA publishes a draft guidance updating with GDUFA 3 commitments a 2020 guidance on generic drug development controlled correspondence.

FDA General

ODT Launches Leadership Modernization Action Plan

FDA launches a digital technology Leadership Modernization Action Plan.

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.

FDA Approves Rozlytrek Companion Diagnostic

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