A User Guide To FDA’s Expedited Programs For Serious Conditions
Executive Summary
A handy side-by-side chart shows the criteria, advantages and timelines for the fast-track, breakthrough therapy and priority review designations and the accelerated approval pathway.
Please click here for a quick reference guide providing an overview of key elements of FDA’s four expedited drug development and review programs, including qualifying criteria, features and benefits, timelines and other considerations for sponsors.
The chart was adapted by “The Pink Sheet” from FDA’s May 2014 final guidance, “Expedited Programs for Serious Conditions – Drugs and Biologics” (see related story, (Also see "FDA Expedited Pathways Guidance Expands Range Of Eligible Products" - Pink Sheet, 9 Jun, 2014.).
Other recent stories of interest on the expedited programs include:
- (Also see "Accelerated Approval Great For “Me-Too” Products, FDA Says" - Pink Sheet, 16 Jun, 2014.)
- (Also see "Genetic Diseases Could See Indication Expansions Through Accelerated Approval" - Pink Sheet, 16 Jun, 2014.)
- (Also see "“Breakthrough” Designation: FDA Clarifies How To Get It – And How It Can Be Lost" - Pink Sheet, 29 May, 2014.)
- (Also see "Accelerated Approval May Support Smaller Trials In Acute Diseases – FDA" - Pink Sheet, 2 Jun, 2014.)
- (Also see "Accelerated Approval Labeling Caveat Draws Industry Ire" - Pink Sheet, 6 Jun, 2014.)