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 2015_register executive 2015-01-27 article Notices D09002ee1c7f800f7 D09002ee1c7f80168 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 of a guidance for industry entitled "S10 Photosafety Evaluation of Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance outlines details on when photosafety testing is warranted and on possible assessment strategies; it should be read in conjunction with the ICH M3(R2) guidance, section XIV(14) Photosafety Testing. The purpose of the guidance is to recommend international standards for photosafety assessment and to harmonize such assessments that support human clinical trials and marketing authorization for pharmaceuticals. This guidance finalizes the draft guidance issued on February 4, 2013. 80 FR 4282 https://www.govinfo.gov/app/details/FR-2015-01-27/2015-01406 2015-01406 fr27ja15-48 4164-01-P Docket No. FDA-2013-D-0068 https://www.govinfo.gov/app/details/FR-2015-01-27/2015-01406 https://www.govinfo.gov/content/pkg/FR-2015-01-27/html/2015-01406.htm https://www.govinfo.gov/content/pkg/FR-2015-01-27/pdf/2015-01406.pdf 2 p. 4282 4283 80 FR 4282 International Conference on Harmonisation; S10 Photosafety Evaluation of Pharmaceuticals; Guidance for Industry; Availability; Federal Register Vol. 80, Issue NOTICE 2015-01406 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Docket No. FDA-2013-D-0068 4164-01-P 2015-01406 Notice.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "S10 Photosafety Evaluation of Pharmaceuticals." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). This guidance outlines details on when photosafety testing is warranted and on possible assessment strategies; it should be read in conjunction with the ICH M3(R2) guidance, section XIV(14) Photosafety Testing. The purpose of the guidance is to recommend international standards for photosafety assessment and to harmonize such assessments that support human clinical trials and marketing authorization for pharmaceuticals. This guidance finalizes the draft guidance issued on February 4, 2013.

Submit either electronic or written comments on Agency guidances at any time. Regarding the guidance: Abigail Jacobs, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6474, Silver Spring, MD 20993-0002; Guidance: International Conference on Harmonisation; S10 Photosafety Evaluation of Pharmaceuticals , http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm http://www.regulations.gov Vol. 80, no. 17 Office of the Federal Register, National Archives and Records Administration 2015-01-27 continuing daily deposited born digital 303 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2015-01-27 P0b002ee18ad6cba5 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr27ja15 https://www.govinfo.gov/app/details/FR-2015-01-27 https://www.govinfo.gov/content/pkg/FR-2015-01-27/pdf/FR-2015-01-27.pdf https://www.govinfo.gov/content/pkg/FR-2015-01-27/xml/FR-2015-01-27.xml fdlp 4195 4487 DGPO 2015-01-27 2024-06-02 FR-2015-01-27 machine generated eng FR FR-2015-01-27 80 17