Day: October 5, 2017

In a new guidance released this week FDA revised the CTD and eCTD formats of market approval applications for drugs and biologics (NDA, ANDA and BLA) with the intent to simplify the documents and provide higher flexibility for organizing content. FDA also withdrew two previous guidance documents that described detailed granularity instructions giving excruciating details … Read more

California passed a law this week that requires physicians providing unapproved stem cell therapies to prominently display at multiple locations within the clinic that the stem cell therapy provided by them is not approved by FDA. The intent of the new law is to assure that patients are aware of the unapproved status of the … Read more