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Australia’s Therapeutic Goods Administration is abandoning its goal of 15-day timelines to process GMP clearance filings from overseas manufacturers. Read More
The U.S. Senate Committee on Health, Education, Labor and Pensions postponed a Wednesday vote on the nomination of Scott Gottlieb to be the next commissioner of the FDA. Read More
Scott Gottlieb avoided explicit written commitments to recusing himself from decisions involving nearly two dozen companies named in a senator’s questions. Read More
The European Medicines Agency Committee for Medicinal Products for Human Use recommended 11 medicines for approval, including four orphan drugs and three biosimilars. Read More