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FDA classifies as Class 1 a Roche Diagnostics recall of its CoaguChek XS PT Test Strips due to inaccurate International Normalized...[ Price : $8.95]
FDA issues a draft guidance to assist sponsors develop drugs and biologics to treat chronic hepatitis B viral infections.[ Price : $8.95]
FDA warns against using results from many genetic tests to predict how a patient will respond to a specific medication.[ Price : $8.95]
Federal Register notice: FDA classifies the meprobamate test system into Class 2 (special controls).[ Price : $8.95]
FDA permits the de novo marketing of 23andMes Personal Genome Service Pharmacogenetic Reports as a direct-to-consumer test for pro...[ Price : $8.95]
Federal Register notice: FDA classifies insulin therapy adjustment devices into Class 2 (special controls).[ Price : $8.95]
Federal Register notice: FDA withdraws two proposed medical device rules after determining that they are not currently considered ...[ Price : $8.95]
The HHS Inspector General recommends ways FDA can improve its policies and procedures to address medical device postmarket cyberse...