Considerations for Tissue-Engineered and Regenerative Medicine Product Development Prior to Clinical Trials in the United States-Reference-Cited by-同舟云学术

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Considerations for Tissue-Engineered and Regenerative Medicine Product Development Prior to Clinical Trials in the United States

Published:2010-02 Issue:1 Volume:16 Page:41-54
ISSN:1937-3368
Container-title:Tissue Engineering Part B: Reviews
language:en
Short-container-title:Tissue Engineering Part B: Reviews

Author:

Lee Mark H.¹,Arcidiacono Judith A.¹,Bilek Anastacia M.²,Wille Jeremiah J.³,Hamill Caitilin A.³,Wonnacott Keith M.¹,Wells Martha A.¹,Oh Steven S.¹

Affiliation:

1. Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, Rockville, Maryland.

2. Center for Device and Radiological Health, U.S. Food and Drug Administration, Rockville, Maryland.

3. Office of the Commissioner, U.S. Food and Drug Administration, Rockville, Maryland.

Publisher

Mary Ann Liebert Inc

Subject

Biomedical Engineering,Biochemistry,Biomaterials,Bioengineering

Link

https://www.liebertpub.com/doi/pdf/10.1089/ten.teb.2009.0449

Reference2 articles.

1. Overview of FDA Regulatory Process

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