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PAS Classification Category Guidance

[ Price : $8.95]

FDA publishes a draft guidance with information on prior approval supplement classification categories A-F.

Comments Sought on Drug Supply Tracing Tech

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Federal Register notice: FDA seeks stakeholder comments on a Drug Supply Chain Security Act-mandated technology and software asses...

Info Collection on Radioactive Drug Committees

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Federal Register notice: FDA sends to OMB an information collection extension entitled Radioactive Drug Research Committees.

Explain FDA Vaccine Approval Process: Study

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The Annenberg Public Policy Center recommends steps to reduce misinformation about the RSV vaccine and promote its use by pregnant...

FDA Approves Janssens Talvey

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FDA gives accelerated approval to Janssens Talvey to treat some adult multiple myeloma patients.

Underrepresented Population Data Guidance

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FDA publishes a draft guidance on obtaining postmarketing safety and effectiveness information on drugs in historically underrepre...

FDA Updates Regulatory Science Device Catalog

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FDA adds four new and updates nine existing tools in its medical device regulatory science tools catalog.

Cardiosave Intra-aortic Balloon Pumps Recalled

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Datascope/Maquet/Getinge recalls the Cardiosave Hybrid and Rescue Intra-aortic Balloon Pumps because they may shutdown without war...

Accurays VitalHold for Breast Cancer Cleared

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FDA clears an Accuray 510(k) for its VitalHold breast cancer package and its use on the companys Radixact radiation therapy system...

ZimVies Smaller Mobi-C Cervical Disc OKd

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FDA approves a ZimVie PMA supplement for a smaller height of its Mobi-C Cervical Disc in seven sizes to address the anatomical nee...