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The European Medicines Agency’s working group on good clinical practices and inspections outlined its goals for 2017, including plans to prioritize certain site inspections. Read More
Arch Pharmalabs received a Form 483 from the FDA listing numerous problems including water quality, documentation and computer system issues. Read More
Because no drugs exist for delayed graft function prevention, the FDA yesterday issued guidance to help foster discussion between drugmakers and the agency on developing drugs to treat the problem. Read More
An industry group and two drugmakers have filed U.S. Supreme Court briefs backing Amgen’s request that a Federal Circuit ruling be partially affirmed to mandate that biosimilar makers share information and wait six months after an FDA approval to launch a therapy. Read More
Sen. Bernie Sanders (I-Vt.) and Rep. Elijah Cummings (D-Md.) have not halted their investigation into the pricing of Emflaza, pursuing its sale from Marathon to PTC Therapeutics. Read More