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Federal Register

Info Collection on Mammography Quality Standards

Federal Register notice: FDA seeks comments on an information collection extension entitled "Mammography Quality Standards Act Requirements: CFR part ...

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Federal Register

Info Collection on Environmental Impact Considerations

Federal Register notice: FDA sends to OMB an information collection revision entitled: "Environmental Impact Considerations."

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Federal Register

Medical Device Accessories Information Collection

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

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Medical Devices

BD Intraosseous Devices Class 1 Recall

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

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Human Drugs

Menarini/Radius Submit Breast Cancer NDA

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

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Medical Devices

FDA Covid Test Recommendations Based on UMass Study

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

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Human Drugs

Ex-FDA Court Expert Witness Challenged

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

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Human Drugs

Novartis Gets Full Approval for Tabrecta

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

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Medical Devices

ClearPoint Neuro Brain Visualizer Cleared

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

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Human Drugs

Concerns About Drug Shortage Draft Guidance

Two stakeholders raise concerns about an FDA draft guidance on risk management programs to mitigate drug shortage potential.