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International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance on Stability Testing of New Animal Drug Substances and Products (#73), Stability Testing for New Dosage Forms of New Animal Drugs (#74), and Stability Testing: Photostability Testing of New Animal Drug Substances and Products (#75); Availability; Request for Comments
Notices
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United States
Department of Health and Human Services
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Food and Drug Administration
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The Food and Drug Administration (FDA) is announcing the availability for comment of three draft guidance for industry documents entitled ``Stability Testing of New Animal Drug Substances and Products,'' ``Stability Testing for New Drug Dosage Forms of New Animal Drugs,''and ``Stability Testing: Photostability Testing of New Animal Drug Substances and Products.'' These related draft guidance documents have been adapted for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) from guidelines that were adopted by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance is intended to provide guidance on stability testing of new drug substances and products and new dosage forms included as part of registration applications for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States.
63 FR 40721
https://www.govinfo.gov/app/details/FR-1998-07-30/98-20310
98-20310
fr30jy98-72
4160-01-F
Docket No. 98D-0566
https://www.govinfo.gov/app/details/FR-1998-07-30/98-20310
https://www.govinfo.gov/content/pkg/FR-1998-07-30/html/98-20310.htm
https://www.govinfo.gov/content/pkg/FR-1998-07-30/pdf/98-20310.pdf
2 p.
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63 FR 40721
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH); Draft Guidance on Stability Testing of New Animal Drug Substances and Products (#73), Stability Testing for New Dosage Forms of New Animal Drugs (#74), and Stability Testing: Photostability Testing of New Animal Drug Substances and Products (#75); Availability; Request for Comments; Federal Register Vol. 63, Issue
NOTICE
98-20310
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
1998-08-31
Docket No. 98D-0566
4160-01-F
98-20310
Notice; request for comments.
The Food and Drug Administration (FDA) is announcing the availability for comment of three draft guidance for industry documents entitled ``Stability Testing of New Animal Drug Substances and Products,'' ``Stability Testing for New Drug Dosage Forms of New Animal Drugs,''and ``Stability Testing: Photostability Testing of New Animal Drug Substances and Products.'' These related draft guidance documents have been adapted for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) from guidelines that were adopted by the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance is intended to provide guidance on stability testing of new drug substances and products and new dosage forms included as part of registration applications for approval of veterinary medicinal products submitted to the European Union, Japan, and the United States.
Written comments should be submitted by August 31, 1998.
Regarding the guidance documents: William G. Marnane, Center for Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-0678, e-mail ``wmarnane@bangate.fda.gov''.
Federal Register
Vol. 63, no. 146
Office of the Federal Register, National Archives and Records Administration
1998-07-30
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190 p.
Table of Contents:
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https://www.govinfo.gov/app/details/FR-1998-07-30
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https://www.govinfo.gov/app/details/FR-1998-07-30
https://www.govinfo.gov/content/pkg/FR-1998-07-30/pdf/FR-1998-07-30.pdf
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