Accelerating the development of therapeutic products intended to treat serious conditions and unmet medical needs have been an increasing interest of the public, legislators, and the scientific community for many years.
Responding to this interest, the FDA has issued regulations and guidance documents to establish development programs designed to speed the availability of new therapies to patients with serious conditions, especially when there are no satisfactory alternative therapies.
Veristat regulatory experts created an infographic to highlight the benefits of, qualifying criteria for, and timing and procedures for six different expedited programs and designations. Overall, the purpose of these regulatory pathways is to save time and reduce the cost of bringing therapies to market for serious conditions and unmet medical needs.
View the infographic to learn how to leverage FDA’s expedited pathways to accelerate product development. We outline the requirements, benefits, and procedures for Fast Track Designation, Breakthrough Therapy Designation, Priority Review Designation, and Accelerated Approval. As well as define two newer programs, Regenerative Medicine Advanced Therapy and Qualified Infectious Disease Program.