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FDA publishes a guidance clarifying how it evaluates real-world data to determine if they are sufficient to provide real-world evi...[ Price : $8.95]
FDA selects investigational cholesterol and cancer drugs from Merck for expedited regulatory reviews under its Commissioner's Nati...[ Price : $8.95]
FDA warns Little Rock, AR-based 3D Imaging Drug Design and Development about CGMP and listing violations in its production of posi...[ Price : $8.95]
FDA extends the review of Aldeyra Therapeutics NDA resubmission for reproxalap, pushing back a regulatory decision on the investig...[ Price : $8.95]
FDA publishes a draft guidance aimed at increasing the enrollment of females in clinical trials of drugs and medical devices.[ Price : $8.95]
President Trump appoints Yale epidemiologist Harvey Risch to chair the Presidents Cancer Panel, a move that is raising alarm among...[ Price : $8.95]
FDA releases the form FDA-483 with seven observations from an inspection at the Exton, PA-based ProRx outsourcing facility.[ Price : $8.95]
FDA warns San Diego, CA-based Microvascular Tissue about CGMP violations in its production and marketing of an unapproved new drug...