Day: August 22, 2019

Since 2016, FDA has been compiling a list of endpoints used in clinical trials used to support NDA applications for drugs. The list called the “Clinical Outcome Assessment (COA) Compendium” organizes all the endpoints used in clinical trials by disease area and product, and includes all endpoints used in NDA and Efficacy Supplements to NDAs. … Read more

FDA’s decisions about the products it reviews can be mind-bogglingly subjective. When two products, for the same indication, with almost identical clinical development plans, and developed by the same company, have extremely contrasting FDA review outcomes it makes it impossible for the public to know the true reasons for such diverse decisions. Three year ago, … Read more