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InfuTronix Recalls Malfunctioning Infusion Pumps

[ Price : $8.95]

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.

FDA Fast Track for Compass Biliary Tract Cancer Drug

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FDA grants fast track designation to Compass CTX-009 that is in a Phase 2 study with paclitaxel to treat some biliary tract tumors...

Cancer Trial Eligibility Criteria Guidance

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FDA publishes a draft guidance to help sponsors expand eligibility for cancer drug clinical trials in terms of washout periods and...

Electronic Signatures Info Collection Approved

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Federal Register notice: FDA announces that OMB has approved an information collection entitled Electronic Records: Electronic Sig...

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Federal Register notice: FDA makes available a revised draft guidance entitled Promotional Labeling and Advertising Considerations...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FDA publishes a draft guidance on using patient performance status as eligibility criteria for cancer drug trials.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FDA publishes a draft guidance with recommendations for increasing cancer drug trial participant diversity by selecting appropriat...