284 related articles for article (PubMed ID: 16686924)
1. The government's role in advancing regenerative medicine and tissue engineering - science, safety, and ethics.
Smith DS
Periodontol 2000; 2006; 41():16-29. PubMed ID: 16686924
[No Abstract] [Full Text] [Related]
2. Considerations for tissue-engineered and regenerative medicine product development prior to clinical trials in the United States.
Lee MH; Arcidiacono JA; Bilek AM; Wille JJ; Hamill CA; Wonnacott KM; Wells MA; Oh SS
Tissue Eng Part B Rev; 2010 Feb; 16(1):41-54. PubMed ID: 19728784
[TBL] [Abstract][Full Text] [Related]
3. Regulatory enablers and regulatory challenges for the development of tissue-engineered products in the EU.
Brévignon-Dodin L
Biomed Mater Eng; 2010; 20(3):121-6. PubMed ID: 20930319
[TBL] [Abstract][Full Text] [Related]
4. Rejuvenating Regenerative Medicine Regulation.
Charo RA; Sipp D
N Engl J Med; 2018 Feb; 378(6):504-505. PubMed ID: 29320637
[No Abstract] [Full Text] [Related]
5. [Industrialization of regenerative medicine in Japan].
Sugawara K; Hata K
Clin Calcium; 2008 Dec; 18(12):1751-6. PubMed ID: 19043189
[TBL] [Abstract][Full Text] [Related]
6. Balancing Safety and Innovation for Cell-Based Regenerative Medicine.
Marks P; Gottlieb S
N Engl J Med; 2018 Mar; 378(10):954-959. PubMed ID: 29514023
[No Abstract] [Full Text] [Related]
7. Who is responsible for the safety of food in a global market? Government certification v. importer accountability as models for assuring the safety of internationally traded foods.
Plunkett D; Smith DeWaal C
Food Drug Law J; 2008; 63(3):657-64. PubMed ID: 19031665
[No Abstract] [Full Text] [Related]
8. Regenerative medicine 2.0.
Mason C
Regen Med; 2007 Jan; 2(1):11-8. PubMed ID: 17465770
[No Abstract] [Full Text] [Related]
9. [Standards used in the regulation of medical device in USA].
Hu W; Gu H
Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi; 2007 Nov; 21(11):1263-7. PubMed ID: 18069490
[TBL] [Abstract][Full Text] [Related]
10. Engineering human tissue and regulation: confronting biology and law to bridge the gaps.
Longley D; Lawford P
Med Law Int; 2001; 5(2):101-15. PubMed ID: 14696620
[TBL] [Abstract][Full Text] [Related]
11. The essential element of ethics.
Donawa ME
Med Device Technol; 2004 Jun; 15(5):27-9. PubMed ID: 15285485
[TBL] [Abstract][Full Text] [Related]
12. Regulatory barriers to tissue-engineered products.
Schutte E
Med Device Technol; 2002 Mar; 13(2):27-9. PubMed ID: 11984990
[TBL] [Abstract][Full Text] [Related]
13. FDA's cloning report bypasses ethics, exposes European dilemma.
Vermij P
Nat Biotechnol; 2007 Jan; 25(1):7-8. PubMed ID: 17211377
[No Abstract] [Full Text] [Related]
14. European regulation tackles tissue engineering.
Sanzenbacher R; Dwenger A; Schuessler-Lenz M; Cichutek K; Flory E
Nat Biotechnol; 2007 Oct; 25(10):1089-91. PubMed ID: 17921987
[No Abstract] [Full Text] [Related]
15. [Letters from Washington. Food and Drug Administration and medical technology: at an impasse?].
Gelijns AC
Ned Tijdschr Geneeskd; 1993 Jan; 137(3):146-50. PubMed ID: 8423866
[No Abstract] [Full Text] [Related]
16. Complying with US and European complaint handling requirements.
Donawa ME
Med Device Technol; 1997 Sep; 8(7):12-5. PubMed ID: 10174197
[TBL] [Abstract][Full Text] [Related]
17. Advancing FDA's regulatory science through weight of evidence evaluations.
Cormier JW
J Contemp Health Law Policy; 2011; 28(1):1-22. PubMed ID: 22292318
[No Abstract] [Full Text] [Related]
18. The implications of "advanced therapies" regulation.
Sethe SC
Rejuvenation Res; 2010; 13(2-3):327-8. PubMed ID: 20462386
[TBL] [Abstract][Full Text] [Related]
19. Modification and consumer information: modern biotechnology and the regulation of information.
Beales JH
Food Drug Law J; 2000; 55(1):105-17. PubMed ID: 12322718
[No Abstract] [Full Text] [Related]
20. Understanding US labelling requirements.
Donawa M
Med Device Technol; 2005 Sep; 16(7):21-3. PubMed ID: 16259155
[TBL] [Abstract][Full Text] [Related]
[Next] [New Search]