Federal Register notice: FDA withdraws approval of six ANDAs from multiple applicants after they notified the agency that the products are no longer m...
Sens. Paul and Hassan reintroduce their bill to require FDA to more clearly identify differences between generic drugs that have been submitted for ap...
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...
Federal Register notice: FDA issues two priority review vouchers to the sponsors of recent rare pediatric disease product applications.
FDA publishes a draft guidance with information for sponsors who are developing certain local anesthetic drug products to produce postoperative analge...
PhRMA suggests changes to an FDA revised draft guidance on the content and format of the Dosing and Administration section of drug labeling.
