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Arrow QuickFlash Radial Artery Catheter Recall

[ Price : $8.95]

Teleflex/Arrow International recalls the Arrow QuickFlash Radial Artery Catheterization Set (wire, guide, catheter) device due to ...

Italfarmaco Wins Approval for Duchenne Drug

[ Price : $8.95]

FDA approves Italfarmacos Duvyzat (givinostat), an oral drug for treating Duchenne Muscular Dystrophy in patients six years of age...

Debarment Order Against Principal Investigator

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Federal Register notice: FDA issues an order to permanently debar Martin Valdes from providing services in any capacity to a perso...

FTC Challenges Teva Orange Book Listings

[ Price : $8.95]

The Federal Trade Commission files an amicus brief calling out Teva Pharmaceuticals for improperly listed patents in FDAs Orange B...

Pemgarda Authorized for Preventing Covid

[ Price : $8.95]

FDA grants Invivyd an emergency use authorization for Pemgarda (pemivibart) and its use for pre-exposure prophylaxis of Covid-19.

FDA Settles Ivermectin Messaging Lawsuit

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FDA agrees to delete its Covid-related social media posts on ivermectin as part of a settlement after three physicians who objecte...

Clarity in RWE Guidance is Welcome: Attorneys

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An online post by attorneys from Hogan Lovells praises FDAs new draft guidance on Real-World Evidence: Considerations Regarding No...

Organon Wants Generic Nexplanon Restrictions

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Organon asks FDA to put restrictions on ANDA applications citing Organons Nexplanon as the reference-listed drug.

4 Observations in Medi-Fare Inspection

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FDA releases the form FDA-483 with four observations from an inspection at Medi-Fare, a Blacksburg, SC, outsourcing facility.

FDA Grants, Denies Draize Test Petition

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FDA grants a Center for Responsible Science petition to the extent that the agency no longer requires or recommends Draize dermal ...