Open AccessConcise Review: The U.S. Food and Drug Administration and Regenerative Medicine
Author(s) -
Witten Celia M.,
McFarland Richard D.,
Simek Stephanie L.
Publication year - 2015
Publication title -
stem cells translational medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.781
H-Index - 71
eISSN - 2157-6580
pISSN - 2157-6564
DOI - 10.5966/sctm.2015-0098
Subject(s) - food and drug administration , regenerative medicine , flexibility (engineering) , agency (philosophy) , multidisciplinary approach , regulatory science , translational medicine , product (mathematics) , engineering ethics , drug development , risk analysis (engineering) , medicine , computer science , microbiology and biotechnology , pharmacology , engineering , drug , political science , biology , pathology , stem cell , management , law , mathematics , philosophy , genetics , geometry , epistemology , economics
Regenerative medicine products regulated by the US Food and Drug Administration (FDA) are classified on the basis of formal regulatory definitions for biologics, medical devices, and combination products, as well as human cells and tissues. FDA efforts to facilitate product development in this promising area for unmet needs include working with individual sponsors, interacting with the scientific and industry communities, participating in standards development, and developing policy and guidance.