Public Citizen files a lawsuit in DC federal court against FDA over a 2016 citizen petition that the agency has not acted on that sought a boxed warni...
FDA accepts for priority review a Bayer NDA for darolutamide for treating non-metastatic castration-resistant prostate cancer.
Federal Register notice: FDA sends to OMB an information collection extension for Administrative Detention and Banned Medical Devices 21 CFR 800.55(g...
FDA revamps its Product-Specific Guidances for Generic Drug Development Web page to add new functionality, including text searching for active ingredi...
FDA clears a CoapTech 510(k) for the PUMA-G System, which enables ultrasound-based placement of percutaneous gastrostomy feeding tubes.
FDA Review posts the Federal Register notices for the week ending 4/26/2019.
FDA Review posts product approval summaries for the week ending 4/26/2019.
Federal Register notice: FDA makes available a final guidance entitled Recommended Content and Format of Non-Clinical Bench Performance Testing Inform...