The FDA’s Accelerated Approval, Breakthrough Therapy, Regenerative Medicine Advanced Therapy, Fast Track, and Priority Review designations were created to help speed up 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.

Taking the time to understand the requirements and potential benefits of each acceleration designation will help you make informed decisions regarding which is the best fit for your program development program.

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