| Dear E, FDA has created several mechanisms to speed the approval of drugs and biologics that effectively treat serious diseases, especially those that are the first of their kind or those that provide increased benefit over existing treatments. In the attached white paper you will find a detailed analysis of FDA's Fast Track, Breakthrough Therapy, Accelerated Approval, Regenerative Medicine Advanced Therapy, and Priority Review designations, along with the eligibility requirements, restrictions, and potential benefits of each. Download this white paper to learn more about: The difference between Accelerated Approval, Breakthrough Therapy, Regenerative Medicine Advanced Therapy, Fast Track, and Priority Review designations Strategies to determine which designation, if any, is right for your program FDA expectations and requirements for each designation |
