Newsletter - August 22, 2019
Did Sarepta Expose the Flaw in FDA Review Process?
FDA’s decisions about the products it reviews can be mind-bogglingly subjective. Two products with similar development plans could end up with contrasting opinions without much transparency making it impossible for the public to know the true reasons for such diverse decisions in turn creating uncertainty for everyone. Read More
FDA Updates Clinical Endpoint List to Help Others Design Better Clinical Trials
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... Read More
Did Sarepta Expose the Flaw in FDA Review Process?
FDA’s decisions about the products it reviews can be mind-bogglingly subjective. Two products with similar development plans could end up with contrasting opinions without much transparency making it impossible for the public to know the true reasons for such diverse decisions in turn creating uncertainty for everyone. Read More
FDA Updates Clinical Endpoint List to Help Others Design Better Clinical Trials
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... Read More
