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Field Correction on Altitude-affected Balloon Pumps

[ Price : $8.95]

Getinge begins a field correction on about 5,223 Maquet/Getinge Cardiosave intra-aortic balloon pumps due to a potential interrupt...

FDA Disagrees with Breast Implant Safety Findings

[ Price : $8.95]

FDA disputes findings published in the Annals of Surgery that suggested an increased risk of certain connective tissue conditions,...

Janssen NDA for Urothelial Cancer Drug

[ Price : $8.95]

Janssen Pharmaceutical files an NDA seeking approval of erdafitinib for treating certain patients with locally advanced or metasta...

California Sues Abbvie Over Illegal Kickbacks

[ Price : $8.95]

California files a lawsut against AbbVie alleging that it gave illegal kickbacks to health care providers to prescribe Humira (ada...

FDA Lifts, Then Dashes LASIK Patients Hopes

[ Price : $8.95]

After a decade of stonewalling injured patients complaints about adverse reactions to LASIK vision-therapy laser surgeries, CDRH l...

Docket Number Corrected on Post-approval Changes Guide

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Federal Register notice: FDA corrects an incorrect docket number appearing in a 9/11 Federal Register notice entitled Post-approva...

3 Drug Product Identifier Guidances

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FDA issues one draft and two final guidances explaining provisions of the Drug Supply Chain Security Act relating to drug product ...

DoJ Argues Against APA Rules Challenges

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Attorney Anne Walsh says the Justice Department has directed its civil litigators to oppose court attempts to impose nationwide in...

Impurity Acceptance Criteria MAPP

[ Price : $8.95]

CDER issues a Manual of Policies and Procedures on establishing drug substance and drug product impurity acceptance criteria for N...

Arca Biopharma Seeks Special Protocol for Heart Failure Trial

[ Price : $8.95]

Arca Biopharma submits a special protocol assessment request for its planned Phase 3 clinical development program of Gencaro (buci...