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Merck Expanded Label for Keytruda Approved

[ Price : $8.95]

FDA approves a Merck expanded label for Keytruda in combination with pemetrexed (Alimta) and platinum chemotherapy for first-line ...

bioMerieux Recalls Vitek 2 AST P631

[ Price : $8.95]

bioMerieux recalls its Vitek 2 AST P631 after customer reports indicate an increase in the rate of non-detected methicillin-resist...

Info Collection Extension on Dispute Resolution Guide

[ Price : $8.95]

Federal Register notice: FDA seeks comments on an information collection extension entitled Guidance for Industry on Formal Disput...

Panel to Review Pediatric Drug Safety

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Federal Register notice: FDA announces a 9/20 Pediatric Advisory Committee to discuss pediatric-focused safety reviews.

Mortality Concerns with SynCardia Artificial Heart

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An FDA review of a post-approval study conducted by SynCardia Systems for its Temporary Total Artificial Heart Companion 2 Driver ...

Quality Metrics Proposal Period Extended

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Federal Register notice: FDA extends the proposal period for its Quality Metrics Site Visit Program for Center for Drug Evaluation...

Info Collection Extension for Generic Development Guide

[ Price : $8.95]

Federal Register notice: FDA submits to OMB an information collection extension entitled Guidance for Industry: Controlled Corresp...

Device Alternative Malfunction Reporting

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Federal Register notice: FDA grants an alternative that permits manufacturer reporting of certain device malfunction medical devic...

Proposal to Classify Device Accessories into Class 1

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Federal Register notice: FDA identifies a list of device accessories for which it believes general controls are sufficient to prov...

FDA Warns on China-sourced API

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FDA alerts active pharmaceutical ingredient repackagers and distributors, and finished drug manufacturers that Sichuan Friendly Ph...