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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 closed out a warning letter issued to West-Ward Pharmaceuticals after the generic drugmaker completed a two-year overhaul of parts of its quality system. Read More
FDA inspectors berated a clinical investigator at New York’s Columbia University Medical Center for failing to properly oversee a clinical trial, despite the university having shut down the study after discovering the violations. Read More
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 closed out a warning letter issued to West-Ward Pharmaceuticals after the generic drugmaker completed a two-year overhaul of parts of its quality system. 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
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 lifted a February 2013 warning letter issued to Jubilant HollisterStier’s manufacturing facility located near Montreal, Canada, and deemed it acceptable after a follow-up inspection in September 2013. 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
GlaxoSmithKline alerted consumers that five lots of its OTC weight loss drug Alli may have been tampered with after fielding complaints that a different drug was in some of the bottles. 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 active pharmaceutical ingredient with conforming batches. Read More
The FDA will hold a public workshop in early May to discuss the development of standards for the interoperable exchange of information pertaining to prescription drug tracing. Read More