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Regulating the Unviable: A Call to FDA for a Rare Biologic Limited Approval (RBLA) Pathway

Year: 2026

Type: article

Source: Cytotherapy

DOI: 10.1016/j.jcyt.2026.102999

Authors: Kevin Bosse, Patrick J. Hanley, Joanna Kurtzberg, Olive Sturtevant, Emily Hopewell, Rebecca Gardner, Bambi J. Grilley

Institutions: Nationwide Children's Hospital, Children's National, George Washington University, Duke University, Dana-Farber Cancer Institute, Indiana University Indianapolis, Indiana University School of Medicine, Indiana University – Purdue University Indianapolis, St. Jude Children's Research Hospital, Houston Methodist, Baylor College of Medicine, Texas Children's Hospital, Dan L Duncan Comprehensive Cancer Center

Language: English

Topic: Biomedical Ethics and Regulation

Subfield: Physiology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: closed

OpenAlex ID: W7204577006

FWCI:

Cites: 9

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