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2010-09-24
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International Conference on Harmonisation; Guideline for the Photostability Testing of New Drug Substances and Products; Availability
Part II
Notices
D09002ee1be01f316
D09002ee1be01f3ac
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 publishing a guideline entitled ``Guideline for the Photostability Testing of New Drug Substances and Products.'' The guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guideline describes the basic testing protocol for photostability testing of new drug substances and products in original new drug application submissions. The guideline is an annex to the ICH guideline entitled ``Stability Testing of New Drug Substances and Products.'' DATES: Effective May 16, 1997. Submit written comments at any time.
62 FR 27116
https://www.govinfo.gov/app/details/FR-1997-05-16/97-12850
97-12850
fr16my97-150
4160-01-F
Docket No. 96D-0010
https://www.govinfo.gov/app/details/FR-1997-05-16/97-12850
https://www.govinfo.gov/content/pkg/FR-1997-05-16/html/97-12850.htm
https://www.govinfo.gov/content/pkg/FR-1997-05-16/pdf/97-12850.pdf
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International Conference on Harmonisation; Guideline for the Photostability Testing of New Drug Substances and Products; Availability; Federal Register Vol. 62, Issue
NOTICE
97-12850
II
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
1997-05-16
Docket No. 96D-0010
4160-01-F
97-12850
Notice.
The Food and Drug Administration (FDA) is publishing a guideline entitled ``Guideline for the Photostability Testing of New Drug Substances and Products.'' The guideline was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guideline describes the basic testing protocol for photostability testing of new drug substances and products in original new drug application submissions. The guideline is an annex to the ICH guideline entitled ``Stability Testing of New Drug Substances and Products.'' DATES: Effective May 16, 1997. Submit written comments at any time.
Effective May 16, 1997. Submit written comments at any time.
Regarding the guideline: Nancy B. Sager, Center for Drug Evaluation and Research (HFD-357), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-594-5721.
Federal Register
Vol. 62, no. 95
Office of the Federal Register, National Archives and Records Administration
1997-05-16
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265 p.
Table of Contents:
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https://www.govinfo.gov/content/pkg/FR-1997-05-16/pdf/FR-1997-05-16.pdf
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