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The European Medicines Agency is considering a draft addendum developed by the International Conference on Harmonization for the ICH’s 1998 clinical trial statistics guideline. Read More
An FDA advisory committee voted 10 to 1 that a muscular dystrophy drug candidate does not have enough supporting data to be considered effective, noting problems with interpreting data from clinical trials. 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
The European Medicines Agency outlined its thoughts on the use of evidence generated through extrapolation techniques in regulatory assessments, in a draft reflection paper. Read More
A federal judge halted sales by a California company that customizes dietary supplements by name and formulation until the company clears an FDA inspection. Read More
The European Medicines Agency will try to maintain “business as usual” for as long as possible throughout the U.K.’s upcoming exit from the European Union, according to a newly released continuity plan. Read More