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Medical Devices

Baxter Recalls Novum IQ Syringe Pump

Baxter recalls its Novum IQ large volume pump after becoming aware of the potential for underinfusion following use of the devices standby mode featur...

Human Drugs

House Subcommittee Advances FDA Budget Bill

A House Subcommittee markup votes along party lines to vote out and advance the agencys FY 2026 spending bill to the full committee.

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Human Drugs

FDA OKs Petition to Correct Phathom Patent Listing

FDA approves a Phathom Pharmaceuticals citizen petition that corrects an agency Orange Book listing to recognize 10 years of new chemical entity exclu...

Medical Devices

FDA: Draeger Recall is Class 1

FDA says a Draeger recall of breathing circuit components is Class 1.

Human Drugs

ICH M11 Technical Specification Guidance Out

FDA publishes the International Council on Harmonization technical representation of its M11 guideline protocol template.

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Human Drugs

House Posts FDA Budget Mirroring Trumps Proposal

The House Appropriations Committee posts FDAs budget bill for FY 2026 that mirrors the Trump Administrations budget proposal that would decrease the a...

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Human Drugs

FDA Platform Technology OK for Sarepta Vector

FDA grants platform technology designation to a Sarepta viral vector used in an investigational gene therapy to treat a form of muscular dystrophy.

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FDA posts a draft guidance entitled Hernia Mesh Package Labeling Recommendations.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