An FDA perspective on preclinical development of cell-based regenerative medicine products

Nature Biotechnology

Volumn 32, Issue 8, 2014, Pages 721-723

  Bailey, Alexander M ^a   Mendicino, Michael ^a,b   Au, Patrick ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b Mesoblast Limited   (Australia)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL THERAPY; FOOD AND DRUG ADMINISTRATION; REGENERATIVE MEDICINE; UNITED STATES;

CELL- AND TISSUE-BASED THERAPY; REGENERATIVE MEDICINE; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 84905732330     PISSN: 10870156     EISSN: 15461696     Source Type: Journal    
DOI: 10.1038/nbt.2971     Document Type: Letter

References (5)

1. United States Code Title 21, Section 312.23(a)(8) http://www.accessdata. fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=312.23.
2. Bailey, A.M. Sci. Transl. Med. 4, 147fs28 (2012).
3. Mendicino, M., Bailey, A.M., Wonnacott, K., Puri, R.K. & Bauer, S.R. Cell Stem Cell 14, 141?145 (2014).
4. Anatol, R. et al. The regulatory process from concept to market. Principles of Tissue Engineering 1781-1797 (Academic Press, 2013).
5. Robinson, R., Bailey, A.M. & Ibrahim, S. Sci. Transl. Med. 3, 94ec124 (2011).