Work

Comparison of Clinical Evidence Submitted to the FDA and EMA for Cell and Gene Therapies

Year: 2025

Type: article

Abstract: This cross-sectional study compares how sponsors approach parallel submissions of gene and cell therapy applications to drug regulatory agencies.

Source: JAMA Internal Medicine

DOI: 10.1001/jamainternmed.2024.7569

Authors: Magdi Elsallab, Sandra Gillner, Florence T. Bourgeois

Institutions: Harvard University, Massachusetts General Hospital, Harvard-MIT Center for Regulatory Science, University of Bern, Boston Children's Hospital

Language: English

Topic: Biomedical Ethics and Regulation

Subfield: Physiology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

OpenAlex ID: W4407087339

FWCI: 2.194

Cites: 2

Cited by: 4

Related to: 10