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Chinese leaders want drugmakers to stop using third-party distributors and sell directly to hospitals in an effort to curb corruption in the supply chain. 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
The FDA has granted Shire’s dry eye treatment lifitegrast a priority review, cutting its NDA review time to six months rather than the usual 10 months. Read More
Drugmakers making major alterations to their products will require a different EU number if they change the specifications or the amount of units contained in a pack, under updated guidelines in Europe. 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
UK inspectors cited 19 companies for critical pharmacovigilance weaknesses in the fiscal year ending March 31, 2014, roughly even with the 18 citations in the previous year. 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 European Commission wants drugmakers to use a risk-management approach to qualify and validate manufacturing processes that covers the lifecycle of the product. Read More