United States Government Publishing Office
publisher
pbl
distributor
dst
United States
National Archives and Records Administration
Office of the Federal Register
author
aut
Government Organization
text
government publication
eng
FR
Regulatory Information
1999_register
executive
2010-09-24
article
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance on VICH GL9 Good Clinical Practices; Request for Comments
Notices
D09002ee1bdfc21ba
D09002ee1bdfc224f
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability for comment of the following draft guidance document entitled: VICH GL9 ``Good Clinical Practices.'' This draft guidance document was developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). It is intended to provide a unified standard for designing, conducting, monitoring, recording, and reporting studies used in registration applications for approval of veterinary products submitted to the European Union, Japan, and the United States.
64 FR 42135
https://www.govinfo.gov/app/details/FR-1999-08-03/99-19871
99-19871
fr03au99-83
4160-01-F
Docket No. 99D-2406
https://www.govinfo.gov/app/details/FR-1999-08-03/99-19871
https://www.govinfo.gov/content/pkg/FR-1999-08-03/html/99-19871.htm
https://www.govinfo.gov/content/pkg/FR-1999-08-03/pdf/99-19871.pdf
2 p.
42135
42136
64 FR 42135
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance on VICH GL9 Good Clinical Practices; Request for Comments; Federal Register Vol. 64, Issue
NOTICE
99-19871
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
1999-09-02
Docket No. 99D-2406
4160-01-F
99-19871
Notice; request for comments.
The Food and Drug Administration (FDA) is announcing the availability for comment of the following draft guidance document entitled: VICH GL9 ``Good Clinical Practices.'' This draft guidance document was developed by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). It is intended to provide a unified standard for designing, conducting, monitoring, recording, and reporting studies used in registration applications for approval of veterinary products submitted to the European Union, Japan, and the United States.
Submit written comments by September 2, 1999. FDA must receive comment before the deadline in order to ensure their consideration.
Regarding VICH: Sharon R. Thompson (HFV-3), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-1798, e-mail: ``sthompso@bangate.fda.gov''.
Federal Register
Vol. 64, no. 148
Office of the Federal Register, National Archives and Records Administration
1999-08-03
continuing
daily
deposited
born digital
272 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-1999-08-03
P0b002ee180a4d359
0097-6326
0042-1219
0364-1406
769-004-00000-9
000582072
f:fr03au99
https://www.govinfo.gov/app/details/FR-1999-08-03
https://www.govinfo.gov/content/pkg/FR-1999-08-03/pdf/FR-1999-08-03.pdf
fdlp
41999
42263
DGPO
2010-09-24
2023-05-05
FR-1999-08-03
machine generated
eng
FR
FR-1999-08-03
64
148