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The FDA has quietly removed a September 2014 warning letter issued to Pacira Pharmaceuticals for touting unapproved uses of its analgesic Exparel. Read More
Brazil’s Anvisa has released guidelines on biological controls, drug manufacturing and clinical trials to harmonize with international standards. Read More
Democratic presidential candidate Hillary Clinton joined the growing chorus of lawmakers and others outraged over Turing Pharmaceuticals’ price hike on Daraprim, pressing the FDA and FTC Monday to broaden access to less expensive drugs. Read More
The FDA’s Office of Planning is calling for better coordination and communications between CDER and CDRH to facilitate reviews of a growing tide of combination therapies. Read More
A U.S. district court judge handed PhRMA a major victory when he vacated an HHS rule requiring Medicaid discounts on orphan drugs in certain healthcare settings, calling it “arbitrary, capricious, [and] an abuse of discretion.” Read More
The FDA Wednesday placed another Indian active pharmaceutical ingredient maker on its import alert list, adding one of Megafine Pharma sites to 46 other India-based finished drug and API sites whose products are banned from entering the U.S. Read More