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The European Medicines Agency’s EudraVigilance system for monitoring adverse events is undergoing an overhaul to comply with new postmarketing clinical trials legislation, and regulators are readying drugmakers and national authorities for a new plan. Read More
Novartis’ generics unit Sandoz received a warning letter from the FDA citing cGMP deficiencies for finished drugs at the company’s plants in Kalwe and Turbhe, India. Read More
Drugmakers are telling the FDA that its proposed biosimilars naming is not necessary, but if four-letter suffixes are needed in the nonproprietary naming of biosimiliars and other biologic products, then make sure those letters are memorable. Read More
The FDA handed SSM Health Care a warning letter for GMP deficiencies in compounding sterile drug products as well as failure to follow 503B conditions for outsourcing facilities at its Fenton, Mo., facility. Read More