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Trial Performance Status Eligibility Criteria Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Performance Sta...

Guide on Washout Period Eligibility Criteria

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Washout Periods...

Elekta Recalls Disposable Biopsy Needles

[ Price : $8.95]

Elekta Instrument recalls its Disposable Biopsy Needles from one batch (837838839) because they possibly contain some microscopic ...

Pfizer Hemophilia B Gene Therapy Approved

[ Price : $8.95]

FDA approves Pfizers Beqvez (fidanacogene elaparvovec-dzkt), a gene therapy for treating adults with moderate to severe hemophilia...

FDA Fast Track for Compass Biliary Tract Cancer Drug

[ Price : $8.95]

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

[ Price : $8.95]

FDA publishes a draft guidance to help sponsors expand eligibility for cancer drug clinical trials in terms of washout periods and...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

[ Price : $8.95]

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Federal Register notice: FDA makes available a revised draft guidance entitled Promotional Labeling and Advertising Considerations...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