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Cancer Trial Performance Status Eligibility Criteria

[ Price : $8.95]

FDA publishes a draft guidance on using patient performance status as eligibility criteria for cancer drug trials.

Laboratory Values Cancer Trial Eligibility Criteria

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FDA publishes a draft guidance with recommendations for increasing cancer drug trial participant diversity by selecting appropriat...

Cardinal Health Monoject Inspection Violations

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FDA warns Cardinal Health it is distributing unapproved medical devices that also have a Quality System Regulation violation.

InfuTronix Recalls Malfunctioning Infusion Pumps

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InfuTronix recalls its Nimbus infusion pump systems due to multiple potential failure modes that may include battery failure, upst...

Expanse ICE Clot Aspiration Device Cleared

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FDA clears an Expanse ICE 510(k) for the ICE Aspiration System for use in peripheral thrombectomy procedures.

Amneal Generic OTC Narcan Spray OKd

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FDA approves an Amneal Pharmaceuticals ANDA for a generic over-the-counter naloxone hydrochloride nasal spray, 4mg, (generic Narca...

Cut Ozempic/Wegovy Price: HELP Committee

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Sen. Bernie Sanders and the HELP Committee call on Novo Nordisk to significantly reduce the cost of its Ozempic and Wegovy in the ...

Curio Postpartum Depression Device Cleared

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FDA clears a Curio Digital Therapeutics 510(k) for its MamaLift Plus, a prescription digital therapeutic for treating postpartum d...

Zydus Lifesciences Issued Another FDA-483

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An FDA inspection at Zydus Lifesciences injectable manufacturing site in Jarod, India results in a 10-observation Form FDA-483, th...

Dr. Reddys Recalls Sapropterin Dihydrochloride

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Dr. Reddys Laboratories recalls six lots of sapropterin dihydrochloride powder for oral solution 100 mg due to decreased potency. ...