Four Food and Drug Administration draft guidance documents and the REGROW Act: A litmus test for future changes in human cell- and tissue-based products regulatory policy in the United States?-Reference-Cited by-同舟云学术

Four Food and Drug Administration draft guidance documents and the REGROW Act: A litmus test for future changes in human cell- and tissue-based products regulatory policy in the United States?

Published:2018-05-21 Issue:7 Volume:12 Page:1579-1593
ISSN:1932-6254
Container-title:Journal of Tissue Engineering and Regenerative Medicine
language:en
Short-container-title:J Tissue Eng Regen Med

Author:

Yano Kazuo¹²³^ORCID,Speidel Alessondra T.¹,Yamato Masayuki¹^ORCID

Affiliation:

1. Institute of Advanced Biomedical Engineering and Science; Tokyo Women's Medical University; Tokyo Japan

2. Research Institute for Science and Engineering; Waseda University; Tokyo Japan

3. Cooperative Major in Advanced Biomedical Sciences; Joint Graduate School of Tokyo Women's Medical University and Waseda University; Tokyo Japan

Publisher

Wiley

Subject

Biomedical Engineering,Biomaterials,Medicine (miscellaneous)

Reference66 articles.

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2. Cetrulo , K. 2016 Call to action to support the REGROW Act https://parentsguidecordblood.org/en/news/call-action-support-regrow-act

3. Coffman , M. Takai , M. Griffith , H. M. 2016 A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to cellular therapies: Reliable and Effective Growth for Regenerative Health Options that Improve Wellness (REGROW Act) https://www.congress.gov/114/bills/hr4762/BILLS-114hr4762ih.pdf https://doi.org/10.1136/bmjopen-2016-013096

4. Stem the tide;Editorial;Nature,2015

5. FDA should stand firm on stem-cell treatments;Editorial;Nature,2016

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