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FDA publishes a draft ICH guidance on post-marketing individual case study reporting.[ Price : $8.95]
FDA medical reviewers ask the Oncology Drug Advisory Committee to weigh the benefits of the benefits and serious risks of Gerons i...[ Price : $8.95]
FDA asks the Oncologic Drugs Advisory Committee to evaluate the higher risk of early deaths in trials supporting sBLAs for Celgene...[ Price : $8.95]
Mintz attorney Benjamin Zegarelli says FDA needs to develop creative ways to regulate software as a medical device while it waits ...[ Price : $8.95]
FDA associate commissioner for global policy and strategy Mark Abdoo says the agency is requesting funds to begin expanding its fo...[ Price : $8.95]
A petition submitted by a Charles Ludlam calls on FDA to require additional clinical trials to examine the loss of lean muscle mas...[ Price : $8.95]
FDA grants MindMed a breakthrough designation for its MM120 (lysergide d-tartrate) program for treating generalized anxiety disord...[ Price : $8.95]
Pharmaceutical Research and Manufacturers of America says FDA should allow drug companies to seek waivers from the one-page patien...