United States Government Publishing Office
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government publication
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FR
Regulatory Information
2018_register
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2018-04-10
article
E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population; International Council for Harmonisation; Guidance for Industry; Availability
Notices
D09002ee1bdb91d30
D09002ee1bdb91dc2
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population'' (E11(R1) addendum or addendum). The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance is an addendum to the guidance published in 2000 entitled ``E11 Clinical Investigation of Medicinal Products in the Pediatric Population'' (ICH E11 (2000)), and provides updates to the original guidance. This addendum does not alter the scope of the original guidance, which outlines an approach to the safe, efficient, and ethical study of medicinal products in the pediatric population. This addendum complements and provides clarification and current regulatory perspective on topics in pediatric drug development. The guidance is intended to provide high-level guidance on the implementation of important approaches in pediatric drug development. This harmonized addendum will help to define the current recommendations and reduce the likelihood that substantial differences will exist among regions for the acceptance of data generated in pediatric global drug development programs and ensure timely access to medicines for children.
83 FR 15581
https://www.govinfo.gov/app/details/FR-2018-04-11/2018-07375
2018-07375
fr11ap18-57
4164-01-P
Docket No. FDA-2016-D-3848
https://www.govinfo.gov/app/details/FR-2018-04-11/2018-07375
https://www.govinfo.gov/content/pkg/FR-2018-04-11/html/2018-07375.htm
https://www.govinfo.gov/content/pkg/FR-2018-04-11/pdf/2018-07375.pdf
3 p.
15581
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83 FR 15581
E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population; International Council for Harmonisation; Guidance for Industry; Availability; Federal Register Vol. 83, Issue
NOTICE
2018-07375
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2016-D-3848
4164-01-P
2018-07375
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population'' (E11(R1) addendum or addendum). The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance is an addendum to the guidance published in 2000 entitled ``E11 Clinical Investigation of Medicinal Products in the Pediatric Population'' (ICH E11 (2000)), and provides updates to the original guidance. This addendum does not alter the scope of the original guidance, which outlines an approach to the safe, efficient, and ethical study of medicinal products in the pediatric population. This addendum complements and provides clarification and current regulatory perspective on topics in pediatric drug development. The guidance is intended to provide high-level guidance on the implementation of important approaches in pediatric drug development. This harmonized addendum will help to define the current recommendations and reduce the likelihood that substantial differences will exist among regions for the acceptance of data generated in pediatric global drug development programs and ensure timely access to medicines for children.
The announcement of the guidance is published in the Federal Register on April 11, 2018.
Regarding the guidance: Lynne Yao, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 22, Rm. 6406, Silver Spring, MD 20993-0002, 301-796-2141; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240- 402-7911. Regarding the ICH: Amanda Roache, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993-0002, 301-796-4548.
Guidance:
E11(R1) Addendum: Clinical Investigation of Medicinal Products in Pediatric Population; International Council for Harmonisation
,
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 83, no. 70
Office of the Federal Register, National Archives and Records Administration
2018-04-11
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2018-04-11
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https://www.govinfo.gov/app/details/FR-2018-04-11
https://www.govinfo.gov/content/pkg/FR-2018-04-11/pdf/FR-2018-04-11.pdf
https://www.govinfo.gov/content/pkg/FR-2018-04-11/xml/FR-2018-04-11.xml
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