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The Senate Health, Education, Labor and Pensions (HELP) Committee has scheduled April 26 for its vote on the confirmation of Scott Gottlieb to be the next commissioner of the FDA. Read More
South Africa’s Medicines Control Council (MCC) released a draft guideline listing minimum requirements for quality manuals that medical device importers, manufacturers, distributers, exporters, and wholesalers must maintain. Read More
A legislative discussion draft being floated in Congress would require the FDA to develop one set of regulations governing both in vitro diagnostics (IVDs) and laboratory-developed tests (LDTs) — to create a more predictable and timely path to market. Read More