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FDA Clears At-home Pulse Baby Monitor

[ Price : $8.95]

FDA clears an Owlet 510(k) for its BabySat, an at-home pulse-oximetry device for monitoring babies.

FDA OKs New Colonoscopy Prep

[ Price : $8.95]

FDA approves Sebelas Suflave colonoscopy prep that reportedly tastes like a sports drink and thus is easier to use.

Suggestions for Pharmacogenomic Data

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Five stakeholders express appreciation for a revised FDA draft guidance on pharmacogenomic data submissions and suggest changes to...

Support In-Home Opioid Disposal: AGs

[ Price : $8.95]

Thirteen state attorneys general call on FDA to develop a plan for disposal of opioid drugs that includes at-home, single-use disp...

Rubio Questions Decision on Cisplatin Imports

[ Price : $8.95]

Senator Marco Rubio questions FDAs decision to temporarily permit the importation of unapproved cisplatin, an important chemothera...

FDA OKs Jardiance/Synjardy for Pediatric Diabetes

[ Price : $8.95]

FDA approves Boehringer Ingelheims Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as treatment...

Reps Urge FDA Relief on Compounded Hormones

[ Price : $8.95]

Twenty-five bipartisan House representatives urge FDA to create patient-centered policies on compounded hormones that maintain pat...

Guide on LDTs Used With Cancer Drugs

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Federal Register notice: FDA makes available a final guidance entitled Oncology Drug Products Used with Certain In Vitro Diagnosti...

Former Tellus Researcher Diaz Debarred

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Federal Register notice: FDA permanently debars Daylen Diaz from providing services in any capacity to a person that has an approv...

Add Plant-Based Diet Notice to Some Agonists: Petition

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The Physicians Committee for Responsible Medicine asks FDA to require a notice on all glucagon-like peptide-1 receptor agonists th...