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The FDA should issue guidance officially adopting U.S. Pharmacopeia standards in its visual particle inspections of injectable drugs, law firm Hogan Lovells says in a Wednesday citizen petition submitted to the agency on behalf of an unnamed drugmaker. Read More
Drugmakers can reduce the time it takes to obtain marketing authorization from EU regulators by about two months if they seek scientific advice and make suggested changes to their clinical development plans, a new analysis shows. Read More
Drugmakers should summarize medication errors that don’t result in adverse reactions in periodic safety update reports and in their risk-management plans, the European Medicines Agency says. Read More
The FDA’s Office of Pharmaceutical Quality is developing a new inspection protocol that will focus on expert investigator-developed questions and assessment practices. Read More
Teva is asking the U.S. Supreme Court to overturn a Pennsylvania state court ruling that would let individuals sue generics makers for failing to promptly update their labels in response to new safety concerns, a move some experts say directly contradicts federal statutes. Read More
A drug safety committee in the EU wants manufacturers of ibuprofen to update their labeling to warn patients of a slightly increased risk of cardiovascular death when the painkiller is taken in high doses. Read More