Snapshot

The FDA Regenerative Medicine Advanced Therapy Designation pathway has been developed by the US Food and Drug Administration of United States.

This pathway accelerates the regulatory review process.

It is an abridged review (a reliance pathway).

No later than 60 calendar days after receipt of the designation request, the Office of Tissues and Advanced Therapies (OTAT) will notify the sponsor as to whether RMAT designation has been granted. If OTAT determines that the RMAT designation request was incomplete or that the drug development program does not meet the criteria for RMAT designation, OTAT will include a written description of the rationale for such determination.