Which statement is TRUE regarding expedited programs for regenerative medicine therapy products?

The statement that advantages of the Regenerative Medicine Advanced Therapy (RMAT) Designation include all benefits of Fast Track and Breakthrough Therapy Designations is true. The RMAT designation is aimed at regenerative medicine products that show the potential to address unmet medical needs. This designation not only expedites the development and review process, but it also provides various benefits that enhance the likelihood of clinical and regulatory success.

By incorporating advantages from both the Fast Track and Breakthrough Therapy Designations, RMAT allows for more frequent interactions with the FDA, a rolling submission of the biologics license application, and potential eligibility for accelerated approval. This synergy of benefits underlines the supportive framework designed specifically to facilitate the development of regenerative therapies, which can often be complex and technologically advanced.

It's important to note that the other statements do not accurately reflect the specifics of expedited programs for regenerative medicine products. For example, immediate approval does not occur across all therapy types, as safety and efficacy must still be demonstrated, and expedited programs work to streamline, not eliminate, regulatory processes. Similarly, while expedited programs may help reduce the length of clinical trials, they do not guarantee a reduction in duration. Lastly, while RMAT designation does confer some degree of market exclusivity, it is not