FDA has issued a draft guidance, “Integrating Randomized Controlled Trials for Drug and Biological Products into Routine Clinical Practice,” which, when finalized, will support the conduct of randomized controlled trials with streamlined protocols and procedures that focus on essential data collection, allowing integration of research into routine clinical practice.
In his first sit-down interview since beginning his role as FDA commissioner 17 days earlier, Marty Makary, a former Johns Hopkins surgeon and the only Trump pick for HHS whose confirmation received Democratic support, said he would speed up approvals for rare-disease treatments by reducing reliance on animal testing and shifting towards organoids and computational models.
