Human cells, tissues, and cellular and tissue-based products; donor screening and testing, and related labeling. Interim final rule; opportunity for public comment
- PMID: 15915582
Item in Clipboard
Human cells, tissues, and cellular and tissue-based products; donor screening and testing, and related labeling. Interim final rule; opportunity for public comment
Fed Regist.
.
Free article
Abstract
The Food and Drug Administration (FDA) is issuing an interim final rule to amend certain regulations regarding the screening and testing of donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps), and related labeling. FDA is taking this action in response to comments from affected interested persons regarding the impracticability of complying with certain regulations as they affect particular HCT/Ps.
Similar articles
-
Revisions to Exceptions Applicable to Certain Human Cells, Tissues, and Cellular and Tissue-Based Products. Final rule.Fed Regist. 2016 Jun 22;81(120):40512-8. Fed Regist. 2016. PMID: 27373010
-
Eligibility determination for donors of human cells, tissues, and cellular and tissue-based products. Final rule.Fed Regist. 2004 May 25;69(101):29785-834. Fed Regist. 2004. PMID: 15160713
-
Human tissue intended for transplantation--FDA. Interim rule; opportunity for public comment.Fed Regist. 1993 Dec 14;58(238):65514-21. Fed Regist. 1993. PMID: 10131341
-
Four Food and Drug Administration draft guidance documents and the REGROW Act: A litmus test for future changes in human cell- and tissue-based products regulatory policy in the United States?J Tissue Eng Regen Med. 2018 Jul;12(7):1579-1593. doi: 10.1002/term.2683. Epub 2018 May 21. J Tissue Eng Regen Med. 2018. PMID: 29702746 Free PMC article. Review.
-
Authentication of human cell-based products: the role of a new consensus standard.Regen Med. 2011 Mar;6(2):255-60. doi: 10.2217/rme.11.5. Regen Med. 2011. PMID: 21391858 Review.
Cited by
-
A Review of Skin Banking Guidelines and Standards Worldwide: Towards the Harmonization of Guidelines for Skin Banking in Therapeutic Applications for the Regions under the Asia Pacific Burn Association (APBA).Burns Trauma. 2020 Oct 20;8:tkaa019. doi: 10.1093/burnst/tkaa019. eCollection 2020. Burns Trauma. 2020. PMID: 33123605 Free PMC article. Review.
-
Human immunodeficiency virus/acquired immunodeficiency syndrome and infertility: emerging problems in the era of highly active antiretrovirals.Fertil Steril. 2011 Sep;96(3):546-53. doi: 10.1016/j.fertnstert.2011.05.094. Epub 2011 Jun 30. Fertil Steril. 2011. PMID: 21722892 Free PMC article. Review.
-
The effect of donor age on corneal transplantation outcome results of the cornea donor study.Ophthalmology. 2008 Apr;115(4):620-626.e6. doi: 10.1016/j.ophtha.2008.01.003. Ophthalmology. 2008. PMID: 18387407 Free PMC article. Clinical Trial.
MeSH terms
Substances
LinkOut - more resources
Full Text Sources
Medical
