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Angela J. Bowen, a medical research pioneer, philanthropist and founder of Western Institutional Review Board, which grew to become the world’s largest independent review board, died at her home in Olympia, Washington on Aug. 31. Read More
The FDA is looking to improve the design of clinical trials and it plans to get involved with sponsors earlier in the development process for new drugs, and to help speed the drugs to market, Commissioner Scott Gottlieb said. Read More
The FDA sent Intellipharmaceutics a complete response letter for Rexista — an extended-release oxycodone tablet rejected in July by an FDA advisory committee — calling for additional clinical studies of the drug’s abuse-deterrent properties. Read More
An FDA advisory committee deadlocked 6 to 6 on whether the benefits of a Pfizer drug treatment for recurrent renal cell carcinoma outweighed the risks. FDA representatives noted the drug was associated with more toxicities than the placebo in clinical trials. Read More
The FDA is committed to using real-world evidence in drug approvals and post-market evaluations, and forthcoming guidance will describe RWE and its potential for satisfying FDA’s pre- and post-market requirements. Read More
Three quarters of clinical trial managers still report challenges loading data into their EDC systems, which in turn increases the time it takes to build study databases, according to new research from the Tufts Center for the Study of Drug Development and Veeva Systems. Read More
Examining how well medical device companies engage with patients in clinical trials is becoming part of the new normal at the FDA, say agency officials. Read More
Intellipharmaceutics artificially inflated its stock prices during the NDA process for its oxycodone product Rexista, a new class-action lawsuit claims. Read More
Managing drug treatments for children may call for communicating with them via Facebook, videos or comics, the European Medicines Agency said in draft guidance on pharmacovigilance practices for pediatric populations. Read More
The European Medicines Agency released a reflection paper to help guide generic drugmakers through the process of setting specifications for in vitro dissolution of immediate-release oral drugs. 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