#FDA's Breakthrough Therapy Designation Process

"A request for Breakthrough Therapy designation should be submitted concurrently with, or as an
amendment to an Investigational New Drug Application (IND) with a cover letter, a completed
form 1571,..." Read a good synopsis of the process and advantages of the designation here.


"No later than 60 days after receipt of the submission, a determination will be made to either grant
or deny the request for Breakthrough Therapy designation in the form of a designation letter (for
requests granted) and a non-designation letter (for requests denied)."