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FDA: Draeger Recall is Class 1

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

ICH M11 Technical Specification Guidance Out

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

House Posts FDA Budget Mirroring Trumps Proposal

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

FDA Platform Technology OK for Sarepta Vector

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

New Safety-Related Hernia Mesh Label Recommendations

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FDA posts a draft guidance entitled Hernia Mesh Package Labeling Recommendations.

Drug Labeling Improved for Pregnant Women: FDA

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

4 States Want Mifepristone REMS Ended

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

Makary Pushes for Reductions in Regulatory Barriers

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FDA commissioner Marty Makary promises that the agency will listen to stakeholder ideas on reducing regulatory barriers and evolvi...

QS Issues at DFI Company

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

Pay Attention to FDA AI Reviews: Attorneys

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