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Exploring an Expedited Regulatory Pathway for Cell and Gene Therapies

Research in regenerative medicine and cell and gene therapy (CGT) is extremely arduous with many challenges on the path to approval, such as complex study design, patient populations with complicated considerations and distinct operational delivery requirements in the clinical trial setting.

Recognizing that these complexities could hinder important therapies reaching patients in a timely manner, the FDA established the Regenerative Medicine Advanced Therapy designation (RMAT) in 2017. Since it is still relatively new, the RMAT designation and its benefits aren’t widely known or understood.

This paper discusses the key benefits of RMAT designation, implications and requirements to be aware of, and considerations for how and when to seek this evolved regulatory pathway.

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