Historical announcement — February 15, 2019. FDA announced an Established Conditions Pilot Program involving certain drug and biologics applications and supplements. This post is retained for historical reference and does not indicate that applications are currently being accepted
FDA is announcing the opportunity for a limited number of applicants to participate in an Established Conditions Pilot Program to propose explicit established conditions (ECs) as part of an original new drug application (NDA), abbreviated new drug application (ANDA), biologics license application (BLA), or as a prior approval supplement (PAS) to any of these.
Please click on the link below to read the entire article posted on the Federal Register website.