FDA publishes a draft guidance on requesting reconsideration of ANDA decisions to reflect the current GDUFA reauthorization.
In a project conducted with FDA, the Clinical Trials Transformation Institute identifies barriers to timely and complete reporting of clinical trials ...
FDA revises its guidance entitled Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as...
Alcon announces positive topline results from two pivotal Phase 3 clinical trials (COMET-2 and COMET-3) evaluating the efficacy and safety of AR-15512...
Federal Register notice: FDA announces the issuance of a priority review voucher to Takeda Pharmaceuticals for its qualified rare pediatric disease pr...
Federal Register notice: FDA announces the issuance of a priority review voucher to Amryt Pharmaceuticals for its qualified rare pediatric disease pro...
FDA grants Sellas Life Sciences a fast track designation for SLS009, a highly selective CDK9 inhibitor for treating relapsed/refractory acute myeloid ...
FDA launches a new search function on its Office of Pharmaceutical Quality Web page to improve access to drug quality resources.
