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BD Recalls Pumps Over Syringe Incompatibility

[ Price : $8.95]

Becton Dickinsons Carefusion unit recalls (Class 1) its Alaris Infusion Pumps due to compatibility issues with Cardinal Health Mon...

Info Collection on Compounder Registration

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension for the registration of human drug compounding outso...

Class 3 for Certain Wound Dressings

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Federal Register notice: In separate rulemakings, FDA proposes to classify into Class 3 certain types of wound dressings and liqui...

FDA Fast Track for eFFECTORs Zotatifin

[ Price : $8.95]

FDA grants fast-track designation to eFFECTOR Therapeutics for its zotatifin in combination with two other drugs as a second- or t...

FDA Checking Chinese Syringe Safety

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FDA says it is evaluating possible safety issues with some plastic syringes manufactured by several firms in China.

Chief Scientist Tapped as Woodcock Replacement

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FDA commissioner Robert Califf names agency chief scientist Namandj Bumpus as the replacement for retiring principal deputy commis...

More Novo Nordisk Semaglutide Legal Actions

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Novo Nordisk says it is seeking legal action against two compounding pharmacies it says are selling adulterated and misbranded dru...

AbbVie Seeks Accelerated OK for Lung Cancer Drug

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Based on new clinical study data, AbbVie says it will seek accelerated approval for telisotuzumab-vedotin in patients with c-Met p...

Info Collection on Combination Product Jurisdiction

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Federal Register notice: FDA sends to OMB an information collection extension entitled Product Jurisdiction and Combination Produc...

UCB on Pregnancy Safety Studies

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UCB makes suggestions for FDA to consider in developing a framework to optimize post-approval pregnancy safety studies.