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Promo Labeling Guide for Biologic Products

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Federal Register notice: FDA makes available a revised draft guidance entitled Promotional Labeling and Advertising Considerations...

FDA Tightening Research Use Only Tests: Lawyers

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Three SheppardMullin attorneys say that manufacturers of tests labeled for research use only should review customer lists and prom...

Fresenius Recalls Stay-Safe Catheter Sets

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Fresenius Medical Care recalls its Stay-Safe Catheter Extension Sets and Stay-Safe/Luer Lock Adapters to correct their instruction...

Cancer Trial Performance Status Eligibility Criteria

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FDA publishes a draft guidance on using patient performance status as eligibility criteria for cancer drug trials.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FDA publishes a draft guidance with recommendations for increasing cancer drug trial participant diversity by selecting appropriat...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 ...