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CDRH says it has recognized and supports industrys use of a key consensus standard "ANSI/AAMI SW96:2023 Standard for medical devic...[ Price : $8.95]
Teleflex and subsidiary Arrow International recall their Pressure Injectable Catheter Kits due to mislabeling about the presence o...[ Price : $8.95]
Law firm Sidley petitions FDA on behalf of an unnamed client asking that it not grant orphan-drug exclusivity to Pyros Pharmaceuti...[ Price : $8.95]
Kodiak Sciences says it will conduct another clinical study to support a single BLA for tarcocimab tedromer and its use in three e...[ Price : $8.95]
FDA approves a Phathom Pharmaceuticals NDA for Voquezna (vonoprazan) tablets 10 mg and 20 mg, a potassium-competitive acid blocker...[ Price : $8.95]
FDA posts a final guidance entitled Submitting Patient-Reported Outcome Data in Cancer Clinical Trials.[ Price : $8.95]
Federal Register notice: FDA identifies certain Class 2 clinical electronic thermometers that, when this action is finalized, will...[ Price : $8.95]
The House Committee on Oversight and Accountability calls on FDA to provide extensive information on its response to a growing num...