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Medical Devices

GLP Report Translation Q&A Guidance

FDA publishes a draft guidance with questions and answers on translating GLP study reports into English.

Human Drugs

Concerns Over FDA Biosimilar Labeling Draft Guide

Four stakeholders differ on an FDA draft guidance suggesting a new approach to biosimilar labeling on interchangeability.

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Human Drugs

Repeat CGMP Violations at Cipla Plant

FDA warns Cipla about CGMP and other violations at its Madhya Pradesh, India-based drug manufacturing facility.

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Medical Devices

SoClean Recalls CPAP Device Cleaners

SoClean recalls its SoClean2 and SoClean3 equipment that is used to clean, sanitize, or disinfect CPAP sleep apnea devices and accessories.

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Study New Guide on Science Info for MDs: Attorneys

Three Epstein Becker Green attorneys analyze a new FDA draft guidance on communicating scientific information on unapproved uses of medical products.

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Medical Devices

Medtronics Symplicity for Hypertension Approved

FDA approves a Medtronic PMA for its Symplicity Spyral renal denervation system for treating hypertension.

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Human Drugs

Abecma Review Delayed for Panel Input

FDA delays a 12/16-expected review decision on a Bristol Myers Squibb and 2seventy bio supplemental BLA for Abecma (idecabtagene vicleucel) and its us...

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Federal Register

Meeting on Rare Disease Patient Engagement

Federal Register notice: FDA announces a 12/14 public meeting entitled Advancing the Development of Therapeutics Through Rare Disease Patient Communit...

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Federal Register

Info Sought on Supply Chain Security

Federal Register notice: FDA seeks information to better understand the status of trading partners interoperable systems and processes for enhanced dr...

Marketing

Final Rule on DTC Ads Major Statements

A new final rule outlines five standards that the agency says drug marketers must follow to ensure their direct-to-consumer advertisements major state...