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Warning Letter on Unapproved Hand Sanitizers

[ Price : $8.95]

FDA sends Prefense LLC a Warning Letter for marketing unapproved hand sanitizers for preventing Covid-19.

Device Conformity Assessment Pilot Info

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Federal Register notice: FDA sends to OMB a new information collection entitled Accreditation Scheme for Conformity Assessment (AS...

Device Co. Kickback Scheme Costs Physician $1.75 Million

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The federal government announces that Virginia physician Jeffrey R. Carlson has agreed to pay $1.75 million to resolve allegations...

FDA Mulls Covid-19 Serology Test Policy Change

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FDA tells a Congressional briefing that it is considering tougher requirements on Covid-10 serology (antibody) tests that are on t...

FDA Approves Neurocrine Parkinsons Drug

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FDA approves a Neurocrine Biosciences NDA for Ongentys (opicapone) 25 mg and 50 mg capsules as an add-on treatment to levodopa/car...

Safety Update on Obesity Gastric Balloons

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FDA sends a letter to health care providers to update risk information for gastric balloon devices used for weight loss.

CytoDyn Files BLA Modules for HIV Therapy

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CytoDyn files clinical and chemistry, manufacturing and controls portions of a BLA for leronlimab as a combination therapy in HIV ...

FDA Contemplates Patent License to Sciofen

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Federal Register notice: FDA announces it is contemplating a grant of an exclusive patent license to Sciogen for two patents on in...

Bayer Gets Reporting Variance on Essure MDRs

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FDA grants a Bayer request for a variance from some medical device reporting requirements regarding its controversial Essure contr...

Comments Extended on Minority Strategic Priorities

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Federal Register notice: FDA reopens for 60 days the comment period for a 1/3 Federal Register notice seeking input from intereste...