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Drugmakers want to know when changes to chemical, manufacturing and controls in NDAs, ANDAs and BLAs must be reported to the U.S. Food and Drug Administration, saying draft guidance lacks clear criteria and examples. Read More
Industry groups questioned whether the U.S. Food and Drug Administration has the legal authority to enforce its quality metrics guidance during an Aug. 24 public meeting on the draft document. Read More
The European Medicines Agency’s medical literature monitoring service kicked into full operation Sept. 1, allowing drugmakers to easily search for information on adverse reactions associated with their products. Read More
Lapses in quality management systems and adverse event reporting topped the list of major deviations found during EU postmarking inspections last year, with 18 sites cited for QMS issues and 13 for AE reporting. Read More
The U.S. Food and Drug Administration released long-awaited draft guidance on Aug. 27 on naming biological products, proposing that both reference products and biosimilars have nonproprietary names comprised of the core drug substance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