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Stem Cell Res Ther 2012 Sep 28;3(5):38

US Food and Drug Administration international collaborations for cellular therapy product regulation.

Arcidiacono JA, Blair JW, Benton KA

Abstract

Cellular therapy products are an emerging medical product class undergoing rapid scientific and clinical innovation worldwide. These products pose unique regulatory challenges both for countries with existing regulatory frameworks and for countries where regulatory frameworks for cellular therapy products are under development. The United States Food and Drug Administration (US FDA) has a history of productive working relationships with international regulatory authorities, and seeks to extend this to the cellular therapy field. The US FDA and its global regulatory counterparts are engaged in collaborations focused on the convergence of scientific and regulatory approaches, and the education of scientists, clinicians, regulators, and the public at large on the development of cellular therapies.


Category: Journal Article, Review
PubMed ID: #23021082
Includes FDA Authors from Scientific Area(s): Biologics
Entry Created: 2012-10-02 Entry Last Modified: 2013-03-15
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