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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
The European Commission released new rules clarifying the responsibilities of qualified persons overseeing global, multisite manufacturing operations and the data they need to collect. Read More
The European Medicines Agency’s decision to redact certain personal and commercial information from clinical study reports before releasing them to a private citizen did not violate EU transparency policy, the European ombudsman says. Read More