Vinay Prasad, Chief Medical and Scientific Officer at FDA, shared a post by FDA on LinkedIn:
“We continue to find ways to slash unnecessary and/or burdensome regulations while upholding gold standard science.”
Quoting FDA‘s post:
“Today, we published draft guidance designed to facilitate the use of Bayesian methodologies in clinical trials of drugs and biologics, helping sponsors make better use of available data and conduct more efficient clinical trials.
The guidance provides recommendations on the appropriate use of Bayesian methods, with a primary focus on the use of these methods to support primary inference.
For more information and to submit a comment about this draft guidance.”
