FDA says that it is now resuming generic in-person face-to-face meetings with generic drug industry members in a phased-in approach while also allowin...
FDA makes available a final guidance entitled Soft (Hydrophilic) Daily Wear Contact Lenses Performance Criteria for Safety and Performance Based Path...
FDA clears a Vaporox 510(k) for its next-generation VHT-200 medical device system for healing chronic wounds.
Iovance Biotherapeutics files a rolling BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy for treating certain patients with adva...
Federal Register notice: FDA posts a draft guidance entitled Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics.
Federal Register notice: FDA announces the fee rates under the over-the-counter monograph drug user fee program for fiscal year 2023.
FDA issues two final guidances on transition plans for Covid-19-related medical devices that were granted emergency use authorizations or were allowed...
Pushing randomized clinical trials, FDA issues a draft guidance entitled Clinical Trial Considerations to Support Accelerated Approval of Oncology The...
