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Beleaguered Indian generics maker Wockhardt is conducting its third U.S. recall since the end of April — this time pulling 162,142 cartons of drugs used to treat high blood pressure and ulcers. Read More
Drugmakers in the EU have less than eight months to conduct risk assessments of all the excipients they use, under good manufacturing practices guidelines imposed by the European Commission. Read More
The European Medicines Agency has issued draft guidance on the manufacture of finished dosage forms, clarifying what information drugmakers should include in the quality section of the common technical document that is part of a premarket application. Read More
Drugmakers making changes to analytical methods over the lifecycle of a drug should retain samples to permit comparative studies of the new and old methods, the FDA says. Read More
South Carolina drugmaker Trans Ox was rapped for major deviations in good manufacturing practices and quality controls after FDA investigators found cobwebs on equipment used to analyze drug batches. Read More
The FDA wants manufacturers to better control the amount of excess drug or biologic they put in injectable vials and ampules to ensure proper patient dosing. Read More
Drugmakers in the EU have less than eight months to conduct risk assessments of all the excipients they use, under good manufacturing practices guidelines imposed by the European Commission. Read More
Beleaguered Indian generics maker Wockhardt is conducting its third U.S. recall since the end of April — this time pulling 162,142 cartons of drugs used to treat high blood pressure and ulcers. Read More