PhRMA suggests changes to an FDA revised draft guidance on the content and format of the Dosing and Administration section of drug labeling.
FDA revises the fact sheets on Janssens Covid-19 vaccine to include a warning about reported adverse events that suggest increased risks of myocarditi...
FDA clears a TytoCare 510(k) for its Tyto Insights for Wheeze Detection, an algorithm for use on the companys existing artificial intelligence-powered...
FDA warns Orlando, FL-based Profounda about CGMP violations in its production of finished drugs as a contract manufacturer.
House Select Subcommittee on the Coronavirus Pandemic Republican leaders ask FDA for communications and interviews relating to potential political int...
Four stakeholders provide additional information to the U.S. Patent and Trademark Office about its collaboration with FDA.
FDAers in CDER and the Oncology Center of Excellence discuss the use of minimal residual disease (MRD) data in hematologic clinical trials and treatme...
Servier says a Phase 3 clinical trial assessing glioma drug vorasidenib met its primary and secondary endpoints.
