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The FDA is scaling back the number of routine quality inspections it plans to conduct in the U.S. each year by 40 percent in favor of conducting more inspections overseas. Read More
The HHS Office of Inspector General (OIG) this year plans to analyze the findings from FDA inspections of generic drugmakers’ facilities to determine the effectiveness of inspections on ensuring the quality of generic medicines. 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
Although great strides have been made by Chinese officials to improve the quality of drugs made in the country, more needs to be done, according to U.S. regulators and drug safety advocates. 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 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