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.
The U.S. Food and Drug Administration released long-awaited draft guidance on Aug. 27 on naming biological products, proposing that both reference products and biosimilars have nonproprietary names comprised of the core drug substance name and a different four-letter suffix. Read More
Before wasting time and money on a clinical trial, sponsors should determine whether additional preclinical studies are needed to rule out a drug candidate’s potential for endocrine-related adverse effects, the FDA says. Read More
The European Medicines Agency is seeking feedback on the International Conference on Harmonization’s revised E6 guideline, which adds new recommendations for sponsors on developing risk-based quality management systems for clinical trials. Read More
The China State Council is calling for sweeping reforms of the country’s drug regulatory system, including accelerated approvals of novel drugs, specified timelines for deciding applications and increased public access to applications and information. Read More
The FDA on Friday approved Wellstat Therapeutics’s Xuriden to treat a rare metabolic disorder known as hereditary orotic aciduria, landing the company a rare pediatric disease priority review voucher. Read More
Yet another Indian drugmaker has been dinged for serious data integrity and GMP issues — this time during a June 4 to 7 inspection by the World Health Organization. Read More
GlaxoSmithKline is recalling more than 427,000 tubes of mupirocin calcium 2% creams and ointments in various sizes due to penicillin cross contamination and the presence of particulates. Read More