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2014-12-09
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General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products; Draft Guidance for Industry; Availability
Notices
D09002ee1bdc37054
D09002ee1bdc370ca
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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.'' The draft guidance is intended to assist those sponsors of new drug applications (NDAs), biologics license applications (BLAs) for therapeutic biologics, and supplements to such applications who are planning to conduct clinical studies in pediatric populations. Effectiveness, safety, or dose finding studies in pediatric patients involve gathering clinical pharmacology information, such as information regarding a product's pharmacokinetics and pharmacodynamics pertaining to dose selection and individualization. This draft guidance addresses general clinical pharmacology considerations for conducting studies so that the dosing and safety information for drugs and biologic products can be sufficiently characterized, leading to well-designed trials to evaluate effectiveness.
79 FR 73079
https://www.govinfo.gov/app/details/FR-2014-12-09/2014-28716
2014-28716
fr09de14-62
4164-01-P
Docket No. FDA-2013-D-1275
https://www.govinfo.gov/app/details/FR-2014-12-09/2014-28716
https://www.govinfo.gov/content/pkg/FR-2014-12-09/html/2014-28716.htm
https://www.govinfo.gov/content/pkg/FR-2014-12-09/pdf/2014-28716.pdf
2 p.
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79 FR 73079
General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products; Draft Guidance for Industry; Availability; Federal Register Vol. 79, Issue
NOTICE
2014-28716
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2013-D-1275
4164-01-P
2014-28716
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products.'' The draft guidance is intended to assist those sponsors of new drug applications (NDAs), biologics license applications (BLAs) for therapeutic biologics, and supplements to such applications who are planning to conduct clinical studies in pediatric populations. Effectiveness, safety, or dose finding studies in pediatric patients involve gathering clinical pharmacology information, such as information regarding a product's pharmacokinetics and pharmacodynamics pertaining to dose selection and individualization. This draft guidance addresses general clinical pharmacology considerations for conducting studies so that the dosing and safety information for drugs and biologic products can be sufficiently characterized, leading to well-designed trials to evaluate effectiveness.
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 February 9, 2015.
Gilbert J. Burckart, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 3184, Silver Spring, MD 20993-0002, 301- 796-2065.
Guidance:
General Clinical Pharmacology Considerations for Pediatric Studies for Drugs and Biological Products
,
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances
http://www.regulations.gov
Federal Register
Vol. 79, no. 236
Office of the Federal Register, National Archives and Records Administration
2014-12-09
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234 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2014-12-09
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https://www.govinfo.gov/app/details/FR-2014-12-09
https://www.govinfo.gov/content/pkg/FR-2014-12-09/pdf/FR-2014-12-09.pdf
https://www.govinfo.gov/content/pkg/FR-2014-12-09/xml/FR-2014-12-09.xml
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