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The FDA has banned Canadian generics maker Apotex from importing drugs to the U.S. made at its Bangalore, India, site, pending quality upgrades. Read More
The FDA has warned GlaxoSmithKline subsidiary SmithKline Beecham over its failure to adequately address contamination of drug ingredients manufactured at its Currabinny, Carrigaline, Cork, Ireland, plant. Read More
A federal court tentatively approved a $60 million payout by Hospira to end a class-action lawsuit that claimed the drugmaker misled investors about its quality problems. Read More
The FDA has outlined the annual fees that large drug compounders that register as outsourcing facilities will have to pay the agency under new federal law. Read More
The FDA chastised another Indian drugmaker for poor quality, this time warning active pharmaceutical ingredient manufacturer Smruthi Organics for not protecting raw data and blending out-of-specification batches of API with conforming batches. Read More
The FDA chastised another Indian drugmaker for poor quality, this time warning active pharmaceutical ingredient manufacturer Smruthi Organics for not protecting raw data and blending out-of-specification batches of API with conforming batches. Read More
To help improve drug safety and quality, the FDA and other countries’ drug industry regulators are considering forming a global authority dubbed the International Coalition of Medical Regulatory Authorities (ICMRA), Commissioner Margaret Hamburg says. Read More
The FDA, working through the International Society for Pharmaceutical Engineering (ISPE), is launching a one-year pilot program examining the feasibility of collecting manufacturers’ quality metrics, a pivotal piece of the agency’s evolving risk-based inspection program. Read More
The database is part of the directorate’s anti-counterfeiting efforts and comes at a time of heightened concern over trafficking of illegal and falsified medicines. Read More
University of Iowa Pharmaceuticals, a contract manufacturer affiliated with the school, received a Form 483 for deficient training materials and poor investigations into quality issues. Read More
U.S. Food and Drug Administration Commissioner Margaret Hamburg said her 10-day trip to India succeeded in syncing U.S.-India views on quality of medical products. Read More
The FDA’s crackdown on compounders continues with two pharmacies receiving warning letters for compounding drugs without a prescription, mixing an unapproved drug ingredient into compounded products and failing to maintain sanitary facilities. Read More