Skip to main content

Advertisement

SpringerLink
Log in

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

  • Correspondence
  • Published:

From Nature Biotechnology

View current issue Submit your manuscript

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Institutional subscriptions

Figure 1: Characteristics of cell-based regenerative medicine products and preclinical testing programs, based on analysis of 163 IND submissions to the FDA/CBER/OCTGT from 2006 to 2013.

References

  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).

    Article  Google Scholar 

  3. Mendicino, M., Bailey, A.M., Wonnacott, K., Puri, R.K. & Bauer, S.R. Cell Stem Cell 14, 141–145 (2014).

    Article  CAS  Google Scholar 

  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).

    Google Scholar 

Download references

Acknowledgements

We thank C. Gacchina Johnson for her contributions to data analysis of regulatory submissions.

Author information

Author notes

  1. Michael Mendicino

    Present address: Present address: Mesoblast Inc., New York, New York, USA.,

Authors and Affiliations

  1. FDA, Center for Biologics Evaluation and Research, Office of Cellular Tissue and Gene Therapies, Silver Spring, Maryland, USA

    Alexander M Bailey, Michael Mendicino & Patrick Au

  2. FDA, Office of Commissioner, Office of Chief Scientist, Office of Regulatory Science and Innovation, Silver Spring, Maryland, USA

    Michael Mendicino

Authors
  1. Alexander M Bailey
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Michael Mendicino
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Patrick Au
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding authors

Correspondence to Alexander M Bailey, Michael Mendicino or Patrick Au.

Ethics declarations

Competing interests

The authors declare no competing financial interests.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Bailey, A., Mendicino, M. & Au, P. An FDA perspective on preclinical development of cell-based regenerative medicine products. Nat Biotechnol 32, 721–723 (2014). https://doi.org/10.1038/nbt.2971

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1038/nbt.2971

  • Springer Nature America, Inc.

This article is cited by

Search

Navigation