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FDA Alert on Breast Implant Illness

[ Price : $8.95]

FDA alerts healthcare professionals and patients about medical device reports detailing breast implant illness with systemic sympt...

AbbVie Antibiotic OKd for Abdominal Infections

[ Price : $8.95]

FDA approves an AbbVie NDA for Emblaveo (aztreonam and avibactam), a combination antibiotic for combination use with metronidazole...

Senate Dems Denounce FDA Communication Freeze

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A group of 24 Senate Democrats write HHS and urge an end to the ongoing and unprecedented freeze on all external communications an...

Alert on Bards Rotarex Atherectomy System

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FDA issues an alert about Bard Peripheral Vasculars Rotarex Atherectomy Systems due to risks of fracture or breakage.

Use Preemption in Failure-to-Market Cases: PRI

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A Pacific Research Institute white paper makes the case for a preemption defense in failure-to-market cases brought under state la...

Court Threatens Practice of Medicine Defense: Attorneys

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Cooley attorneys say a recent 4th Circuit Court of Appeals decision threatens the practice of medicine defense, giving FDA an addi...

Breakthrough Status for Mortality Prognosticator Tool

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FDA grants Onc.AI a breakthrough device designation for its Serial CT Response Score AI model, which the company describes as an a...

Medline Catheter Recall is Class 1

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FDA says the Medline Industries recall of integrated arterial catheters is Class 1.

Trump to Fire Thousands of HHS Workers: Report

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Mainstream media reports based on anonymous sources say the White House is preparing an order to require HHS to fire a percentage ...

Cancer Drug Tabloid ANDA Restrictions Sought

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A Buchanan Ingersoll petition asks FDA to maintain restrictions on cancer drug Tabloid ANDAs that are in the applicable product-sp...