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The International Society for Pharmaceutical Engineering calls on FDA to use a targeted, phased-in approach to start its quality m...[ Price : $8.95]
FasterCures recommends PDUFA 6 language to build collection of patient perspective data into medical product development and regul...[ Price : $8.95]
Concordia asks FDA to update its digoxin bioequivalence guidance with testing recommendations from an advisory committee.[ Price : $8.95]
Researchers in Taiwan say they have identified a biomarker that detects the most common lung cancer in its earliest stage, which c...[ Price : $8.95]
FDA clears a Philosys 510(k) for the Gmate Smart Blood Glucose Monitoring System and app for Android smartphones.[ Price : $8.95]
FDA issues close-out letters to AngioDynamics involving Warning Letters in 2011 about its Queensbury, NY facility and in 2014 abou...[ Price : $8.95]
FDA sends five Warning Letters to manufacturers marketing dietary supplements containing picamilon as a dietary ingredient, asking...[ Price : $8.95]
FDA accepts for review a Medicure supplemental NDA for Aggrastat (tirofiban HCl) that seeks an expanded indication to include trea...