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US FDA outreach to the regenerative medicine community: challenges and opportunities.
MedLine Citation:
PMID:  22817631     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
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.
Authors:
Kevin J Whittlesey; Celia Witten
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Regenerative medicine     Volume:  7     ISSN:  1746-076X     ISO Abbreviation:  Regen Med     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-07-23     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  101278116     Medline TA:  Regen Med     Country:  England    
Other Details:
Languages:  eng     Pagination:  595-603     Citation Subset:  IM    
Affiliation:
California Institute for Regenerative Medicine, 210 King Street, San Francisco, CA 94107, USA. kwhittlesey@cirm.ca.gov.
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