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Boston Scientific Implantable Defibrillator Lead Recall

[ Price : $8.95]

FDA classifies as Class 1 a Boston Scientific recall of its Emblem S-ICD subcutaneous electrode because of an increased risk of fr...

Access Vascular Midline Catheter Cleared

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FDA clears an Access Vascular 510(k) for its HydroMID midline catheter, which is made using the companys proprietary biomaterial t...

CDER Implementing KASA Drug Quality Tool

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CDERs Office of Pharmaceutical Quality says that early this year it will begin using its Knowledge-aided Assessment & Structured A...

948 ANDAs Approved in 2020

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The Office of Generic Drugs annual report says it approved 948 ANDAs during 2020 -- down 223 or 19% deom the previous year -- whil...

FDA Thinking About Vaccine Changes for Variants: Marks

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CBER director Peter Marks says FDA is looking into what it will need to authorize changes to Covid-19 vaccines so they can better ...

Few AI Breast Imaging Products Show Racial Demographics

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A Stat investigation finds that few public summaries of FDA-cleared artificial intelligence products used with breast imaging carr...

Novartis Semaglutide has Gamechanger Obesity Results

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A new study finds that 35% of those taking Novartis semaglutide for treating obesity lost more than one-fifth of their total body ...

Cancer Experts Endorse Woodcock for Commissioner

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Some 94 oncology physicians, researchers, and leaders ask President Biden to nominate Janet Woodcock as FDA commissioner.

Regenerons Evkeeza OKd for Rare High Cholesterol

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FDA approves a Regeneron Pharmaceuticals BLA for Evkeeza (evinacumab-dgnb) as an adjunct to other low-density lipoprotein choleste...

Report Details FDA Drug Safety Efforts

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CDERs sixth annual drug safety report updates the Centers typical safety activities as well as those focused on the Covid-19 pande...