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FDA General

Returning FDA Staff to Face Space, Parking Issues

FDA warns staff returning to offices on 3/17 that they can face parking and workspace issues, Reuters reports.

Medical Devices

Canon Medical Gets AI Cleared for CT Scanner

FDA clears a Canon Medical 510(k) for artificial intelligence enhancements for the Aquilion One/Insight Edition CT scanner.

Human Drugs

Amgen Seeking Expanded Uplizna Use

Amgen says it will file a BLA supplement by 6/30 for Uplizna (inebilizumab-cdon) to expand its use to treat adults living with generalized myasthenia ...

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Medical Devices

FDA Device Data Integrity Notifications

Two Akin Gump attorneys discuss a new FDA Web page with information on medical device data integrity.

Human Drugs

CGMP Deviation in Chemspec Chemicals Inspection

FDA cautions Indias Chemspec Chemicals about a CGMP deviation in its production of active pharmaceutical ingredients.

Human Drugs

7 Acne Products Recalled for Benzene: FDA

FDA says manufacturers are recalling seven acne products containing benzoyl peroxide to the retail level after testing found possible benzene contamin...

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Medical Devices

Regulate NarxCare as Software as Medical Device: Petition

The Doctor Patient Forum petitions FDA to regulate Bamboo Healths NarxCare platform and other prescription drug monitoring program risk-scoring algori...

FDA General

DoJ Lawyer Tapped as FDA Chief Counsel

HHS appoints Justice Department attorney Hilary Perkins to serve as FDA chief counsel.

Medical Devices

J&Js Monarch Quest Bronchoscopy Navigation Cleared

FDA clears a Johnson & Johnson MedTech 510(k) for its Monarch Quest, an advanced navigation technology for robotically assisted bronchoscopy.

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Federal Register

Comments Reopened on Good Clinical Practice Guide

Federal Register notice: FDA reopens the comment period for its draft guidance entitled E6(R3) Good Clinical Practice: Annex 2.