We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Broadening clinical trials eligibility criteria will require re-assessing approaches and a change in culture, according to a panel of FDA representatives, government scientists, academic researchers and members of the pharmaceutical industry. Read More
The European Medicines Agency made several changes to a March 2016 guidance explaining the agency’s policy for publishing sponsors’ clinical trials data, including factors that could lead to rejection. Read More
Fifteen FDA officials, including Commissioner Robert Califf, called for broader uses of research methodologies, such as intervention and randomization, in real-world settings outside the typical venues of clinical trials. Read More
The FDA issued a draft guidance urging sponsors to work to control error rates before launching clinical trials with multiple endpoints, and provided several examples of appropriate statistical methods. Read More
The FDA updated its guidance for botanical drug development to include recommendations for navigating combination drug regulations, with possible criteria for receiving a waiver. Read More