Regulatory issues in Europe and Canada

Xenotransplantation

Volumn 9, Issue 6, 2002, Pages 371-373

  Tallacchini, Mariachiara ^a  

^a UNIVERSITY OF MILAN   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

CANADA; CONSULTATION; ETHICS; EUROPE; HEALTH CARE POLICY; LEGAL ASPECT; MODEL; NOTE; ORGAN TRANSPLANTATION; PATIENT RIGHT; PRIORITY JOURNAL;

ANIMALS; CANADA; ETHICS, MEDICAL; EUROPE; HUMANS; TRANSPLANTATION, HETEROLOGOUS;

EID: 0036872254     PISSN: 0908665X     EISSN: None     Source Type: Journal    
DOI: 10.1034/j.1399-3089.2002.02056_2.x     Document Type: Note

References (12)

1. US Public Health Service. PHS guideline on infectious disease issues in xenotransplantation, January 19, 2001, http://www.fda.gov/cber.
2. DHHS-FDA. Docket no. 00N-0989, CBER 9863. Availability for public disclosure and submission to FDA for public disclosure of certain data and information related to human gene therapy or xenotransplantation. [FR Doc. 01], January 18, 2001, 4688. http://www.fda.gov/OHRMS/ DOCKETS/98fr/011801b.pdf.
3. FDA-PHS. Draft guidance for industry source animal, product, preclinical, and clinical issues concerning the use of xenotransplantation products in humans, February 2001. Http://www.fda.gov/cber/guidelines.htmFDA-PHS, Draft. Guidance for industry: precautionary measures to reduce the possible risk of transmission of zoonoses by blood and blood products from xenotransplantation product recipients and their intimate contacts. February 1, 2002, http://www.fda.gov/cber/gdlns/zoobldxeno.pdf.
4. FDA-PHS. Draft guidance for industry source animal, product, preclinical, and clinical issues concerning the use of xenotransplantation products in humans, February 2001. Http://www.fda.gov/cber/guidelines.htmFDA-PHS, Draft. Guidance for industry: precautionary measures to reduce the possible risk of transmission of zoonoses by blood and blood products from xenotransplantation product recipients and their intimate contacts. February 1, 2002, http://www.fda.gov/cber/gdlns/zoobldxeno.pdf.
5. COE Working Party on Xenotransplantation. State-of-the-art report on xenotransplantation, Strasbourg, 7 July 2000, CDBI/CDSP-XENO 2000 12. The report has been amended in 2001: Report on the State-of-the-art in the field of xenotransplantation, Strasbourg, 5 September 2001, CDBI/CDSP-XENO 2001 13. For a comment see: M. Tallacchini, Council Europe Working Party Xenotransplantation: State-of-the-Art Report Xenotransplantation 2000, 'Xenotransplantation' 2001; 8: 154.
6. COE Working Party on Xenotransplantation. State-of-the-art report on xenotransplantation, Strasbourg, 7 July 2000, CDBI/CDSP-XENO 2000 12. The report has been amended in 2001: Report on the State-of-the-art in the field of xenotransplantation, Strasbourg, 5 September 2001, CDBI/CDSP-XENO 2001 13. For a comment see: M. Tallacchini, Council Europe Working Party Xenotransplantation: State-of-the-Art Report Xenotransplantation 2000, 'Xenotransplantation' 2001; 8: 154.
7. CDBI/CDSP. Draft Recommandation on Xenotransplantation of the Committee of Ministers to Member States on Xenotransplantation, Strasbourg, 8 October 2001. Restricted; CDBI/CDSP, Draft Explanatory Report to the Draft Recommandation on Xenotransplantation, Strasbourg, 22 October 2001, Restricted.
8. Scientific Committee on Medicinal Products and Medical Devices. Opinion on the state-of-the-art concerning xenotransplantation. Brussels: Health and Consumer Protection Directorare General, European Commission, 1st October 2001, http://europa.eu.int/comm/food/fs/sc/ scmp/out38_en.pdf.
9. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use, OJEC 121/34, 2001.
10. Consiglio Superiore di Sanit. Linee-guida per la Sperimentazione Clinica degli Xenotrapianti. Roma: Ministero della Salute, 2002.
11. Pontificia Academia Pro Vita. La prospettiva degli xenotrapianti. Aspetti scientifici e con siderazioni etiche, http://www.vatican.va/roman_curia/pontifical_academics/ acdlife/documents/rc_pa_acdlife_doc_xenotrapian-ti_it.html.
12. Canadian Public Health Association. Animal-to-human transplantation: should Canada proceed? A public consultation on xenotransplantation. Ottawa: CPHA December 2001, http://www.xeno.cpha.ca/english/finalrep/ reporte.pdf.