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2013-02-02
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International Conference on Harmonisation; Draft Guidance on S10 Photosafety Evaluation of Pharmaceuticals; Availability
Notices
D09002ee1bdcaa735
D09002ee1bdcaa7c7
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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``S10 Photosafety Evaluation of Pharmaceuticals.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. The draft guidance includes criteria for initiation of and triggers for additional photosafety testing and should be read in conjunction with the ICH M3(R2) guidance, section XIV(14) Photosafety Testing. The purpose of the draft guidance is to recommend international standards for photosafety assessment and to harmonize such assessments that support human clinical trials and marketing authorization for pharmaceuticals.
78 FR 7786
https://www.govinfo.gov/app/details/FR-2013-02-04/2013-02296
2013-02296
fr04fe13-72
4160-01-P
Docket No. FDA-2013-D-0068
https://www.govinfo.gov/app/details/FR-2013-02-04/2013-02296
https://www.govinfo.gov/content/pkg/FR-2013-02-04/html/2013-02296.htm
https://www.govinfo.gov/content/pkg/FR-2013-02-04/pdf/2013-02296.pdf
2 p.
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78 FR 7786
International Conference on Harmonisation; Draft Guidance on S10 Photosafety Evaluation of Pharmaceuticals; Availability; Federal Register Vol. 78, Issue
NOTICE
2013-02296
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2013-D-0068
4160-01-P
2013-02296
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``S10 Photosafety Evaluation of Pharmaceuticals.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation (ICH) of Technical Requirements for Registration of Pharmaceuticals for Human Use. The draft guidance includes criteria for initiation of and triggers for additional photosafety testing and should be read in conjunction with the ICH M3(R2) guidance, section XIV(14) Photosafety Testing. The purpose of the draft guidance is to recommend international standards for photosafety assessment and to harmonize such assessments that support human clinical trials and marketing authorization for pharmaceuticals.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by March 21, 2013.
Regarding the guidance: Abigail Jacobs, Center for Drug Evaluation and Research (ONDIO), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6484, Silver Spring, MD 20993-0002, 301-796-0174.
International Conference on Harmonisation; Draft Guidances; Availability:
S10 Photosafety Evaluation of Pharmaceuticals
,
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.regulations.gov
Federal Register
Vol. 78, no. 23
Office of the Federal Register, National Archives and Records Administration
2013-02-04
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https://www.govinfo.gov/app/details/FR-2013-02-04
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https://www.govinfo.gov/app/details/FR-2013-02-04
https://www.govinfo.gov/content/pkg/FR-2013-02-04/pdf/FR-2013-02-04.pdf
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