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FDA Top Lawyer Resigns After 2 Days on the Job

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Just-appointed FDA chief counsel Hilary Perkins abruptly resigns her post after two days on the job.

SpringWorks Therapeutics Awarded Priority Voucher

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Federal Register notice: FDA issues a priority review voucher was issued to SpringWorks Therapeutics for achieving a 2/11 NDA appr...

QApel Selling Unapproved Aspiration System: FDA

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FDA warns Fremont, CA-based QApel Medical about illegally marketing an aspiration system with Quality System Regulation violations...

One-third of MAUDE Reports Submitted Late: Study

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Researchers say that nearly one-third of adverse event reports submitted to the FDA MAUDE medical device database came in later th...

Senate Committee Advances Makarys FDA Nomination

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The Senate Health Education Labor and Pensions Committee votes to advance the nomination of Marty Makary as FDA commissioner.

Returning FDA Staff to Face Space, Parking Issues

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

Canon Medical Gets AI Cleared for CT Scanner

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

Amgen Seeking Expanded Uplizna Use

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

FDA Device Data Integrity Notifications

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

CGMP Deviation in Chemspec Chemicals Inspection

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