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Medtronic Spinal Cord Stimulator OKd

[ Price : $8.95]

FDA approves a Medtronic PMA for the Inceptiv closed-loop rechargeable spinal cord stimulator for treating chronic pain.

Marks Outlines CBER 2024 Top Priorities

[ Price : $8.95]

CBER director Peter Marks outlines the top priorities at the Center this year that include updating the Centers tissue guidance to...

Lab Values for Cancer Trial Eligibility Guide

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Laboratory Valu...

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Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Performance Sta...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Federal Register notice: FDA makes available a draft guidance entitled Cancer Clinical Trial Eligibility Criteria: Washout Periods...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

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FDA publishes a draft guidance to help sponsors expand eligibility for cancer drug clinical trials in terms of washout periods and...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