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2010-09-23
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International Conference on Harmonisation; Stability Data Package for Registration Applications in Climatic Zones III and IV; Stability Testing of New Drug Substances and Products; Availability
Notices
D09002ee1bdeb0f40
D09002ee1bdeb0fe5
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 two guidances prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The first is a guidance entitled ``Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV'' (the Q1F guidance). The second is a revised guidance entitled ``Q1A(R2) Stability Testing of New Drug Substances and Products'' (the Q1A guidance). The Q1F guidance, which is an annex to the Q1A guidance, defines an approach for broader use of the Q1A guidance for territories in climatic zones III and IV. The revised Q1A guidance incorporates relevant Q1F recommendations.
68 FR 65717
https://www.govinfo.gov/app/details/FR-2003-11-21/03-29103
03-29103
fr21no03-79
4160-01-S
Docket No. 2002D-0231 and 1993D-0139
https://www.govinfo.gov/app/details/FR-2003-11-21/03-29103
https://www.govinfo.gov/content/pkg/FR-2003-11-21/html/03-29103.htm
https://www.govinfo.gov/content/pkg/FR-2003-11-21/pdf/03-29103.pdf
2 p.
65717
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68 FR 65717
International Conference on Harmonisation; Stability Data Package for Registration Applications in Climatic Zones III and IV; Stability Testing of New Drug Substances and Products; Availability; Federal Register Vol. 68, Issue
NOTICE
03-29103
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2003-11-21
Docket No. 2002D-0231 and 1993D-0139
4160-01-S
03-29103
Notice.
The Food and Drug Administration (FDA) is announcing the availability of two guidances prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The first is a guidance entitled ``Q1F Stability Data Package for Registration Applications in Climatic Zones III and IV'' (the Q1F guidance). The second is a revised guidance entitled ``Q1A(R2) Stability Testing of New Drug Substances and Products'' (the Q1A guidance). The Q1F guidance, which is an annex to the Q1A guidance, defines an approach for broader use of the Q1A guidance for territories in climatic zones III and IV. The revised Q1A guidance incorporates relevant Q1F recommendations.
The guidance is effective November 21, 2003. Submit written comments at any time.
Regarding the guidances: Chi-wan Chen, Center for Drug Evaluation and Research (HFD-830), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-2001; or Andrew Shrake, Center for Biologics Evaluation and Research (HFM-345), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20052-1148, 301-402- 4635.
Harmonization International Conference; guidelines availability:
Stability data package for registration applications in climatic zones III and IV and stability testing of new drug substances and products,
http://www.fda.gov/cber/publications.htm
http://www.fda.gov/cder/guidance/index.htm
http://www.fda.gov/dockets/ecomments
http://www.fda.gov/ohrms/dockets/default.htm
Federal Register
Vol. 68, no. 225
Office of the Federal Register, National Archives and Records Administration
2003-11-21
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212 p.
Table of Contents:
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GS 4.107:
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https://www.govinfo.gov/app/details/FR-2003-11-21
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https://www.govinfo.gov/app/details/FR-2003-11-21
https://www.govinfo.gov/content/pkg/FR-2003-11-21/pdf/FR-2003-11-21.pdf
https://www.govinfo.gov/content/pkg/FR-2003-11-21/xml/FR-2003-11-21.xml
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2010-09-23
2023-05-04
FR-2003-11-21
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