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Medical Device Accessories Information Collection

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Federal Register notice: FDA sends to OMB an information collection extension entitled "Medical Device Accessories."

BD Intraosseous Devices Class 1 Recall

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FDA says the Becton Dickinson recall of three intraosseous medical devices is Class 1.

Menarini/Radius Submit Breast Cancer NDA

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The Menarini Group, supported by Radius Health, submits an NDA to FDA for elacestrant to treat some breast cancers.

FDA Covid Test Recommendations Based on UMass Study

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The UMass Chan Medical School says the results of its study of at-home Covid tests are in an FDA recommendation for serial testing...

Ex-FDA Court Expert Witness Challenged

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The federal court hearing a proton-pump inhibitor liability consolidated case is considering whether a former FDAer who was involv...

Novartis Gets Full Approval for Tabrecta

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FDA grants full approval to Novartis for its previously accelerated-approved Tabrecta (capmatinib) for treating certain adult pati...

ClearPoint Neuro Brain Visualizer Cleared

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FDA clears a ClearPoint Neuro 510(k) for its ClearPoint Maestro Brain Model, software that uses MRI images to conduct labeling, vi...

FDA Updates Device Recognized Standards Listing

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Federal Register notice: FDA makes available a publication entitled Modifications to the List of Recognized Standards, Recognition...

FDA Working on Januvia Shortage

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FDA says it will temporarily allow distribution of some sitagliptin products with the nitrosamine impurity NTTP above acceptable i...

Comments on Radiolabeled Studies Draft

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Five stakeholders comment on an FDA draft guidance on radiolabeled mass balance studies.