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Baxter International issued its sixth recall of intravenous solutions since December 2013, recalling 15 lots — about 237,000 units — because of the potential presence of particulate matter. Read More
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee will meet Tuesday to review the safety of DPP4 inhibitors, a class of diabetes drug the FDA first approved in 2009. Read More
Australia’s Therapeutic Goods Administration is turning to the European Union for guidance as it seeks to adopt 10 guidelines — four new and six replacements — to improve the nation’s drug system. Read More
An FDA request for feedback on its drug compounding regulations is likely to generate questions and comments on GMPs, office-use compounding of nonsterile drugs and more, experts say. Read More
The FDA has warned a French drugmaker for data integrity issues related to the production of active pharmaceutical ingredients at its Thailand manufacturing plant. Read More
Making good on its promise to encourage use of new and better technologies in drug manufacturing, the FDA has issued its first guidance for drugmakers using near infrared technology to measure product quality. Read More
The FDA has handed Hospira its seventh warning letter in seven years and the second in the past six months, this time for poor sterile processing, inadequate batch failure investigations and data integrity weaknesses at its Liscate, Italy, manufacturing plant. Read More
In the next few years, drugmakers will have to collect quality metrics data for FDA investigators to use in determining a facility’s quality status. Metrics being bandied about include batch failure rates, CAPA rates, complaints and right-first-time rates. Read More