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2010-09-24
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Draft “Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans;” Availability
Notices
D09002ee1bdf961f3
D09002ee1bdf96268
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans'' dated February 2001. The draft guidance document is intended to provide guidance on the production, testing, and evaluation of products intended for use in xenotransplantation.
66 FR 9348
https://www.govinfo.gov/app/details/FR-2001-02-07/01-3202
01-3202
fr07fe01-79
4160-01-F
Docket No. 00D-1662
https://www.govinfo.gov/app/details/FR-2001-02-07/01-3202
https://www.govinfo.gov/content/pkg/FR-2001-02-07/html/01-3202.htm
https://www.govinfo.gov/content/pkg/FR-2001-02-07/pdf/01-3202.pdf
1 p.
9348
9348
66 FR 9348
Draft “Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans;” Availability; Federal Register Vol. 66, Issue
NOTICE
01-3202
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2001-05-08
Docket No. 00D-1662
4160-01-F
01-3202
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled ``Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans'' dated February 2001. The draft guidance document is intended to provide guidance on the production, testing, and evaluation of products intended for use in xenotransplantation.
Submit written comments on the draft guidance to ensure their adequate consideration in preparation of the final document by May 8, 2001.
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-6210.
Reports and guidance documents; availability, etc.:
Xenotransplantation products use in humans; source animal, product, preclinical, and clinical issues,
http://www.fda.gov/cber/guidelines.htm
Federal Register
Vol. 66, no. 26
Office of the Federal Register, National Archives and Records Administration
2001-02-07
continuing
daily
deposited
born digital
331 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2001-02-07
P0b002ee180a0b03b
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr07fe01
https://www.govinfo.gov/app/details/FR-2001-02-07
https://www.govinfo.gov/content/pkg/FR-2001-02-07/pdf/FR-2001-02-07.pdf
https://www.govinfo.gov/content/pkg/FR-2001-02-07/xml/FR-2001-02-07.xml
fdlp
9187
9507
DGPO
2010-09-24
2023-05-05
FR-2001-02-07
machine generated
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FR
FR-2001-02-07
66
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