Veristat Resource Library

Understanding FDA Expedited Pathways for Accelerating Time-to-Market for Products Treating Serious Conditions or Unmet Medical Needs

Accelerating the development of therapeutic products intended to treat serious conditions and unmet medical needs has been an increasing interest of the public, legislators, and the scientific community for many years.

Responding to this interest, 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.