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Federal Register notice: FDA posts a draft guidance entitled Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics.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Pushing randomized clinical trials, FDA issues a draft guidance entitled Clinical Trial Considerations to Support Accelerated Approval of Oncology The...
Federal Register notice: FDA releases CDER/CBERs Framework for the Use of Digital Health Technologies in Drug and Biological Product Development.
CBER's Office of Therapeutic Products plans a 4/27 public listening meeting to obtain feedback on methods and approaches for capturing post-approval s...
