We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
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
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
Sun Pharmaceuticals is recalling 5,322 bottles of Ketorolac tromethamine ophthalmic solution in the U.S. and Puerto Rico for failing to meet specifications. Read More
The FDA has halted imports of drugs from two Ipca manufacturing facilities in India due to good manufacturing practice violations, marking the second and third FDA-imposed import alerts against the drugmaker this year. 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