Work

RMAT or BLA. When to chase Regenerative Medicine Advanced Therapy designation, and when to wait.

Year: 2026

Type: article

Abstract: Addresses when a 351(a) sponsor should seek Regenerative Medicine Advanced Therapy designation. Summarizes the RMAT criteria and argues the designation helps but is not a shortcut to licensure.

Source: Zenodo (CERN European Organization for Nuclear Research)

DOI: 10.5281/zenodo.23352261

Author: Hillman, Andrew Jonathan

Language: English

Topic: Biomedical Ethics and Regulation

Subfield: Physiology

Field: Medicine

Domain: Health Sciences

Open Access status: green

OpenAlex ID: W7221660259

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