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Non-specific Covid-19 Panel Meeting 10/22

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Federal Register notice: FDA announces a 10/22 Vaccines and Related Biological Products Advisory Committee meeting.

More ANDA Product-Specific Guidances

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FDA publishes new product-specific guidances that provide recommendations for developing generic drugs and generating data needed ...

Hahn Removes New Press Head After Controversial Remarks

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FDA commissioner Stephen Hahn fires newly appointed chief spokeswoman Emily Miller in the wake of his controversial remarks exagge...

Synchron Breakthrough Status for Paralysis Brain Device

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FDA grants Synchron a breakthrough device designation for Stentrode, an implantable medical device that can translate brain activi...

FDA Safety Alert on Laws PPE of Motion Gowns

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FDA alerts healthcare facilities to stop using medical gowns, including surgical gowns, manufactured or sold by New York City-base...

Patient Engagement Advisory Panel on Device AI

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Federal Register notice: FDA announces a 10/22 Patient Engagement Advisory Committee meeting.

Draft Guide on CNS Cancer Drugs

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Federal Register notice: FDA makes available a draft guidance entitled Evaluating Cancer Drugs in Patients with Central Nervous Sy...

Cassiopea First-in-Class Acne Drug Approved

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FDA approves a Cassiopea NDA for Winlevi (clascoterone cream 1%) for treating acne in patients 12 years and older.

Teva Charged in Generic Drug Price Fixing

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The Justice Department charges Teva as part of a probe into generic drug price-fixing.

Braun SpaceStation MRI Cleared

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FDA clears a B. Braun Medical 510(k) for the SpaceStation MRI to allow Space infusion pumps to continuously deliver medications to...