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...
FDA accepts for review a Supernus Pharmaceuticals NDA resubmission for its apomorphine infusion device (SPN-830) for the continuous treatment of Parki...
Federal Register notice: FDA makes available a final guidance entitled Enforcement Policy for Clinical Electronic Thermometers.
FDA clears an Empatica 510(k) for two new digital biomarkers for its Empatica Health Monitoring Platform pulse and respiratory rate.
Republican members of the House Energy and Commerce Committee express concern about FDA inaction on the safety of agency laboratory operations and the...
A transition to an improved manufacturing process leads to an FDA partial clinical hold on a Nurix Therapeutics clinical study evaluating NX-2127 in v...
