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Scientific Publications by FDA Staff

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Regen Med 2012 Jul;7(4):595-603

US FDA outreach to the regenerative medicine community: challenges and opportunities.

Whittlesey KJ, Witten C

Abstract

Advances in the field of regenerative medicine have yielded novel approaches to developing treatments for currently unmet medical needs. The regenerative medicine field is diverse, spanning many research and clinical disciplines; no single society or organization fully represents regenerative medicine. The US FDA maintains an active dialog with a variety of stakeholders to keep abreast of the latest available science, to anticipate regulatory challenges posed by the latest scientific developments and to educate stakeholders about regulatory expectations for product development. The diversity of stakeholders in this field makes this dialog challenging. This article provides an overview of some of the FDA's current outreach activities in this area. The FDA welcomes opportunities to enhance its interactions with the regenerative medicine community.


Category: Journal Article, Editorial
PubMed ID: #22817631 DOI: 10.2217/rme.12.36
Includes FDA Authors from Scientific Area(s): Biologics
Entry Created: 2012-08-27 Entry Last Modified: 2012-08-29
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