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Dont Use Antibody Tests After Covid Vaccination: FDA

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An FDA safety communication advises against taking an Covid-19 antibody test for those vaccinated with a Covid vaccine.

Peripheral Atherectomy Device Updated Guidance

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FDA issues an updated final guidance on 510(k) submissions for peripheral vascular atherectomy devices.

Implanted Brain-Computer Interface Device Test Guidance

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FDA issues a leapfrog guidance on non-clinical testing and clinical considerations for implanted brain-computer interface devices....

Guidance on ANDAs for Some Peptides

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FDA issues a guidance on ANDA submissions for some highly purified synthetic peptides.

Glycemic Control Medical Device Guidance

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FDA publishes a draft guidance on clinical studies for glycemic control medical devices.

CBD Product Bill Introduced

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Three senators introduce legislation to allow FDA to regulate hemp-derived CBD products like other new dietary ingredients, foods,...

ACRA McMeekin Talks Up New Inspectional Affairs Council

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FDA associate commissioner for regulatory affairs Judy McMeekin updates the Food and Drug Law Institute on inspectional activity o...

FDA Gets HHS Grant to Expand CURE ID Platform

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FDA gets a $9.2 million HHS grant to expand CURE ID for automated data collection from electronic health records and clinical dise...

Draft Guide on Chemo-induced Nausea Drugs

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Federal Register notice: FDA makes available a draft guidance entitled Chemotherapy-Induced Nausea and Vomiting: Developing Drugs ...

Iovance Delays Lifileucel BLA on FDA Feedback

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Iovance Biotherapeutics says FDA regulatory feedback on potency assays for lifileucel will delay a planned BLA for the therapy.