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Human Drugs

New Safety-Related Hernia Mesh Label Recommendations

FDA posts a draft guidance entitled Hernia Mesh Package Labeling Recommendations.

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Human Drugs

Drug Labeling Improved for Pregnant Women: FDA

FDA confirms that all drugs now have updated labeling to better provide health risk information to pregnant women.

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Human Drugs

4 States Want Mifepristone REMS Ended

California, Massachusetts, New Jersey, and New York ask FDA to cancel the mifepristone REMS program requirements in their states or decline to enforce...

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FDA General

Makary Pushes for Reductions in Regulatory Barriers

FDA commissioner Marty Makary promises that the agency will listen to stakeholder ideas on reducing regulatory barriers and evolving its processes by ...

Medical Devices

QS Issues at DFI Company

FDA warns Koreas DFI Co., Ltd. about Quality System and Medical Device Reporting violations in its manufacturing of reagent strips.

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FDA General

Pay Attention to FDA AI Reviews: Attorneys

Three Morgan Lewis attorneys tell regulated product sponsors to watch for AI involvement in FDA reviews and be prepared to respond when necessary.

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Medical Devices

Smiths Issues 3 Recalls on Infusion Pumps

FDA announces three Class 1 recalls (device corrections) by Smiths Medical related to certain CADD [computerized ambulatory delivery device]-Solis Amb...

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Human Drugs

CGMP Issues at Huangshi Hygienic

FDA warns Chinas Huangshi Hygienec Material Medicine Co. about CGMP violations in its manufacturing of finished drugs.

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Human Drugs

Vigil Neuro Ends Trial of Rare Brain Disorder Drug

Vigil Neuroscience ends its Phase 2 long-term extension study of investigational therapy iluzanebart based on disappointing study results.

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Human Drugs

Draft Guide on OTC Drug Minor Changes

FDA posts a draft guidance entitled Recommendations for Complying With Over-the-Counter Monograph Procedure for Minor Changes C001: Minor Changes to S...