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Class 1 Recall for Roche CoaguCheck Test Strips

[ Price : $8.95]

FDA classifies as Class 1 a Roche Diagnostics recall of its CoaguChek XS PT Test Strips due to inaccurate International Normalized...

Hepatitis B Drug Development Guidance Out

[ Price : $8.95]

FDA issues a draft guidance to assist sponsors develop drugs and biologics to treat chronic hepatitis B viral infections.

FDA Warns About Some Genetic Test Predictions

[ Price : $8.95]

FDA warns against using results from many genetic tests to predict how a patient will respond to a specific medication.

Class 2 for Meprobamate Test System

[ Price : $8.95]

Federal Register notice: FDA classifies the meprobamate test system into Class 2 (special controls).

De Novo Marketing for Pharmacogenetic Reports

[ Price : $8.95]

FDA permits the de novo marketing of 23andMes Personal Genome Service Pharmacogenetic Reports as a direct-to-consumer test for pro...

Insulin Therapy Adjustment Devices into Class 2

[ Price : $8.95]

Federal Register notice: FDA classifies insulin therapy adjustment devices into Class 2 (special controls).

2 Medical Device Proposed Rules Scrapped

[ Price : $8.95]

Federal Register notice: FDA withdraws two proposed medical device rules after determining that they are not currently considered ...

Improve FDA Cybersecurity Risk Policies, Procedures: OIG

[ Price : $8.95]

The HHS Inspector General recommends ways FDA can improve its policies and procedures to address medical device postmarket cyberse...

FDA Looking at Balloon Pump Shutdowns

[ Price : $8.95]

FDA says it is evaluating over 75 reports of battery shutdown and other issues with Maquet/Datascope intra-aortic balloon pumps.

FDA Clears OsteoRemedies Spectrum GV Hip Spacer

[ Price : $8.95]

FDA clears an OsteoRemedies 510(k) for the Remedy Spectrum GV Hip Spacer System and Spectrum GV Bone Cement, which are intended to...