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Human Radiolabeled Mass Balance Study Guide

[ Price : $8.95]

FDA publishes a guidance with recommendations on clinical pharmacology considerations for conducting human radiolabeled mass balan...

Guide on Blood Pressure Donor Eligibility

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance entitled Blood Pressure and Pulse Donor Eligibility Requirements: Co...

FDA Discourages BOT/BAL Accelerated Approval

[ Price : $8.95]

FDA recommends that Agenus not submit its BOT/BAL colorectal cancer treatment for accelerated approval.

Zydus Gets Official Action Indicated on Recent Inspection

[ Price : $8.95]

FDA classifies as official action indicated an April inspection of Zydus Lifesciences injectables manufacturing facility at Jarod,...

Aveo Phase 3 Trial Misses Primary Endpoint

[ Price : $8.95]

Aveo Oncology says its Phase 3 trial of Fotivda plus BMS Opdivo in some renal cell cancer patients did not meet the progression-fr...

Globus Knee Arthroplasty Cleared for ExcelsiusFlex

[ Price : $8.95]

FDA clears a Globus Medical 510(k) for its ExcelsiusFlex with total knee arthroplasty option.

Breakthrough Status for Heart Failure Device

[ Price : $8.95]

FDA grants Restore Medical a breakthrough device designation for its ContraBand device and its use in treating certain heart failu...

Phathom Pharma Heartburn Drug Expanded Use

[ Price : $8.95]

FDA approves a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) 10 mg tablets for relieving heartburn associated with non-ero...

2 More Warning Letters for Chinese Plastic Syringes

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FDA says two additional Warning Letters have been issued to Chinese medical device firms as part of its evaluation of defective pl...

7 Observations in Leiters Health FDA-483

[ Price : $8.95]

FDA releases the form FDA-483 with seven observations from an inspection at the Englewood, CO-based Leiters Health outsourcing fac...