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FDA posts a 3/5 complete response letter to Rosemont Pharmaceuticals, rejecting the companys NDA for valacyclovir.[ Price : $8.95]
FDA warns Westphalia, Germany-based Simtra BioPharma Solutions about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
FDA warns Novo Nordisk in Plainsboro, NJ, about its failure to meet postmarketing adverse drug experience reporting requirements.[ Price : $8.95]
FDA warns Frances Fareva about CGMP violations in the production of finished drugs at its Morton Grove, IL, manufacturing facility...[ Price : $8.95]
FDA issues an early alert regarding a potential safety issue with certain Erbe USA Flexible Cryoprobes, following reports that som...[ Price : $8.95]
The Institute for Safe Medicines calls on FDA, the Federal Trade Commission, and the Department of Justice to take enforcement act...[ Price : $8.95]
Five Sidley attorneys recommend ways in which drug companies can analyze their direct-to-consumer promotions to see if they are li...[ Price : $8.95]
FDA cites a U.K.-based clinical research center for failing to promptly report adverse events and for potential falsification of s...