The Department of Justice says former drug sales representative Vincent Tornari pled guilty to one count of healthcare fraud and wire fraud involving ...
An FDA advisory committee briefing document says data support the efficacy of Pfizers Paxlovid (nirmatrelvir and ritonavir) for treating mild-to-moder...
The Government Accountability Office says 15 stakeholders had widely varying views on the listing of drug/device combination product patents in the FD...
FDA publishes a draft guidance with information for sponsors who are developing certain local anesthetic drug products to produce postoperative analge...
PhRMA suggests changes to an FDA revised draft guidance on the content and format of the Dosing and Administration section of drug labeling.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.
