Center for Drug Evaluation & Research Director Janet Woodcock believes that the US FDA has figured out how to get guidances out much more rapidly, touting a “just-say-it” approach that focuses on bullet points and key messages rather than longer, discursive text. (Also see "'Just Say It!' – New Streamlined Guidance Format Coming, FDA's Woodcock Says" - Pink Sheet, 14 November, 2017.)
During the recent Food & Drug Law Institute annual meeting, in fact, Woodcock responded to a question about what is...