FDA & "Fast Track" programm

Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.
Fast track emphasizes the critical nature of close early communication between the FDA and sponsor, procedures such as pre-IND and end of phase 1 meetings as methods to improve the efficiency of preclinical and clinical development, and focuses on efforts by the FDA and sponsor to reach early agreement on the design of the major clinical efficacy studies that will be needed to support approval. Fast Track policies are primarily designed to expedite drug development during the IND stage, whereas Approval under subpart H allows for marketing approval of an NDA based on an effect on a surrogate endpoint along with well-controlled post-marketing studies. Therefore, a drug developed under Fast Track may also qualify for Approval under Subpart H. A general statictics how many such programs were running since introduction in 1998 and lists in detail which products had a benefit from this program see InfoClick.