Awareness of the Role of Science in the FDA Regulatory Submission Process: A Survey of the TERMIS-Americas Membership-Reference-Cited by-同舟云学术

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Awareness of the Role of Science in the FDA Regulatory Submission Process: A Survey of the TERMIS-Americas Membership

Published:2014-06 Issue:11-12 Volume:20 Page:1565-1582
ISSN:1937-3341
Container-title:Tissue Engineering Part A
language:en
Short-container-title:Tissue Engineering Part A

Author:

Johnson Peter C.¹²,Bertram Tim A.²³,Carty Neal R.¹,Hellman Kiki B.²⁴,Tawil Bill J.²⁵,Van Dyke Mark²⁶

Affiliation:

1. Vancive Medical Technologies, Chicago, Illinois.

2. TERMIS-AM Industry Committee, San Ramon, California.

3. Tengion, Inc., Winston-Salem, North Carolina.

4. The Hellman Group, Clarksville, Maryland.

5. Baxter Biosurgery, Inc., Irvine, California.

6. Virginia Polytechnic Institute and State University, Blacksburg, Virginia.

Publisher

Mary Ann Liebert Inc

Subject

Biomedical Engineering,Biomaterials,Biochemistry,Bioengineering

Link

https://www.liebertpub.com/doi/pdf/10.1089/ten.tea.2014.0112

Reference12 articles.

1. Hurdles in Tissue Engineering/Regenerative Medicine Product Commercialization: A Survey of North American Academia and Industry

2. Challenges in Tissue Engineering and Regenerative Medicine Product Commercialization: Building an Industry

3. Hurdles in Tissue Engineering/Regenerative Medicine Product Commercialization: A Pilot Survey of Governmental Funding Agencies and the Financial Industry

4. The Regulatory Imperative: International Perspective

Cited by 6 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Stem cell therapy clinical research: A regulatory conundrum for academia;Advanced Drug Delivery Reviews;2017-12

2. How Regenerative Medicine Stakeholders Adapt to Ever-Changing Technology and Regulatory Challenges? Snapshots from the World TERMIS Industry Symposium (September 10, 2015, Boston);Tissue Engineering Part B: Reviews;2017-04

3. Stem Cell-based Medicinal Products: Regulatory Perspectives;Advanced Surfaces for Stem Cell Research;2016-12-02

4. Regulation Policy on Tissue Engineering and Regenerative Medicine in Asian–Pacific Region;Tissue Engineering Part A;2015-12

5. Enhancing Tissue Engineering and Regenerative Medicine Product Commercialization: The Role of Science in Regulatory Decision-Making for the TE/RM Product Development;Tissue Engineering Part A;2015-10

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