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FDA Reclassifies Surgical Staplers, Staples

[ Price : $8.95]

FDA reclassifies surgical staplers for internal use from Class 1 to Class 2 and delays enforcement of the change for 180 days.

De Novo Sought for Fibromyalgia Neuromodulator

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NeuroMetrix submits a de novo request for its Quell wearable neuromodulation device for treating symptoms of fibromyalgia in adul...

Panel to Discuss Moderna, Janssen Vaccine Boosters

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Federal Register notice: FDA announces a 10/14-15 Vaccines and Related Biological Products Advisory Committee meeting.

Revised Guide on Hospital Drug Compounding

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Federal Register notice: FDA releases a revised draft guidance entitled Hospital and Health System Compounding Under Section 503A ...

Imperative Care Zoom Catheter Recall is Class 1

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FDA says the Imperative Care recall of specific lots of its ZOOM 71 reperfusion catheter is Class 1.

Info Collection Revision on Device Labeling

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Federal Register notice: FDA sends to OMB an information collection revision entitled Medical Device Labeling Regulations.

FDA Recognizes Molecular Tumor Marker Database

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FDA recognizes a partial listing of the Memorial Sloan Kettering Cancer Center Oncology Knowledge Base.

Biden Nearing His FDA Commissioner Pick

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The Biden Administration signals that it is nearing its choice of a nominee for FDA commissioner.

Bill Could End Animal Testing Mandates

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Sens. Paul and Booker introduce legislation to end FDA mandates for animal testing when reliable alternate methods are available.

Immunicom Hires Former FDAer Shenouda

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Immunicom appoints former FDAer Christian Shenouda as vice president of regulatory affairs.