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The European Medicines Agency has hit a snag in its efforts to publish clinical trial data reports, due to long pilot phases for the first publications it made after the policy took effect last October. Read More
A review of legal databases was unable find any liability lawsuits against pharmaceutical companies related to four years’ worth of products used under expanded access, according to a study by FDA researchers. Read More
The European Medicines Agency updated its advice on navigating its centralized pre-authorization procedures to include a section on combination packs of medications. Read More
China’s high court called for severe criminal punishments for deliberately falsifying drug clinical trial reports and other related documents, issuing a judicial interpretation that took effect Sept. 1. Read More
Drugmakers need to provide adequate details — and include narratives — in describing manufacturing processes in their applications, but can leave out elements such as machinery serial numbers and general GMPs, according to the European Medicines Agency. Read More
The FDA posted only 60 ANDA approvals in August — slightly below the year’s monthly average of 63 — plus 17 tentative approvals, an overall dip after a strong showing the previous three months. Read More
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended thirteen products, including its first biosimilar for Genentech’s blockbuster drug Herceptin. Read More
The FDA has largely succeeded in expediting the review of drugs with larger health gains, but postmarket trials by companies have fallen behind in confirming some of those benefits, with many not using the gold standard of randomized controlled trials, according to two independent studies. Read More