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FDA clears a Vaporox 510(k) for its next-generation VHT-200 medical device system for healing chronic wounds.[ Price : $8.95]
Iovance Biotherapeutics files a rolling BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy for treating certai...[ Price : $8.95]
Federal Register notice: FDA posts a draft guidance entitled Clinical Trial Considerations to Support Accelerated Approval of Onco...[ Price : $8.95]
Federal Register notice: FDA announces the fee rates under the over-the-counter monograph drug user fee program for fiscal year 20...[ Price : $8.95]
FDA issues two final guidances on transition plans for Covid-19-related medical devices that were granted emergency use authorizat...[ Price : $8.95]
Pushing randomized clinical trials, FDA issues a draft guidance entitled Clinical Trial Considerations to Support Accelerated Appr...[ Price : $8.95]
Federal Register notice: FDA releases CDER/CBERs Framework for the Use of Digital Health Technologies in Drug and Biological Produ...[ Price : $8.95]
CBER's Office of Therapeutic Products plans a 4/27 public listening meeting to obtain feedback on methods and approaches for captu...