Navigating regulatory pathways for translation of biologic cartilage repair products
Author:
Affiliation:
1. Department of Biomedical Engineering, University of California Irvine, Irvine, CA 92697 USA.
2. Department of Orthopaedic Surgery, University of California Irvine Medical Center, Orange, CA 92868, USA.
Abstract
Publisher
American Association for the Advancement of Science (AAAS)
Subject
General Medicine
Reference149 articles.
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3. U.S. Food and Drug Administration FDA/CBER Guidance for industry: Preclinical assessment of investigational cellular and gene therapy products (2013); www.fda.gov/regulatory-information/search-fda-guidance-documents/preclinical-assessment-investigational-cellular-and-gene-therapy-products.
4. Tissue Engineering
5. Unlike Bone, Cartilage Regeneration Remains Elusive
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