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Human Drugs

FDA Warns Against Topical OTC Analgesics

FDA issues a warning to not use certain over-the-counter analgesic products that are marketed for topical use to relieve pain before, during or after ...

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Federal Register

PARP Inhibitor Ovarian Cancer Indications Withdrawn

Federal Register notice: FDA announces that it is withdrawing approval of the indications for treating adult patients with advanced ovarian cancer for...

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Human Drugs

CGMP Violations at Deqing Jiarou

FDA warns Chinas Deqing Jiarou Daily Chemical Co. about CGMP violations in its production of finished drugs.

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Medical Devices

Multiple Violations in ReNovo Inspection

FDA warns Bend, OR-based ReNovo that its reprocessed single-use medical devices are adulterated and misbranded and have Quality System violations.

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Medical Devices

Rep. Questions Musk Device Trial OK Before Inspection

Rep. Earl Blumenauer asks FDA to explain why it approved human trials for Elon Musks Neuralink medical device before inspecting its facility.

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Human Drugs

Antibody Drug Conjugate Guidance Explained

Two CDER Office of Clinical Pharmacology doctors use a podcast to explain a new guidance on considerations for antibody-drug conjugates.

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Human Drugs

High Court Skeptical on Mifepristone Restrictions

The majority of U.S. Supreme Court justices appear skeptical during oral arguments on whether there should be a ban or any new restrictions on the abo...

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Federal Register

Leonowens Debarred for 5 Years

Federal Register notice: FDA issues an order to debar Phillip Leonowens for a period of five years from importing or offering for import any drug into...

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Federal Register

Clinical Data Interchange Standards Update

Federal Register notice: FDA announces support for the Clinical Data Interchange Standards Consortium Standard for Exchange of Nonclinical Data Implem...

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Medical Devices

Medline Recalls Kits/Tray Over Sterility

Medline Industries recalls certain kits, trays and packs in direct response to Nurse Assists 11/2023 recall of 0.9% sodium chloride irrigation USP and...