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