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2016-04-20
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Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information; Draft Guidance for Industry; Availability
Notices
D09002ee1bdc1c829
D09002ee1bdc1c8ac
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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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information.'' This document is a revised version of a draft guidance that published in February 2003 entitled ``Comparability Protocols: Chemistry, Manufacturing, and Controls Information.'' A related draft guidance entitled ``Comparability Protocols--Protein Drug Products and Biological Products--Chemistry, Manufacturing, and Controls Information,'' that published in September 2003, was withdrawn on May 6, 2015. The revised draft guidance provides recommendations to human drug and biologics manufacturers on implementing a chemistry, manufacturing, and controls (CMC) postapproval change(s) through the use of a comparability protocol (CP). By using a CP, manufacturers who fall within the scope of this guidance will not have to submit commercial- scale CMC information on postchange products to FDA before making the proposed change. This draft guidance is intended to establish a framework to promote manufacturing of quality drug products.
81 FR 23303
https://www.govinfo.gov/app/details/FR-2016-04-20/2016-09137
2016-09137
fr20ap16-69
4164-01-P
Docket No. FDA-2016-D-0973
https://www.govinfo.gov/app/details/FR-2016-04-20/2016-09137
https://www.govinfo.gov/content/pkg/FR-2016-04-20/html/2016-09137.htm
https://www.govinfo.gov/content/pkg/FR-2016-04-20/pdf/2016-09137.pdf
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81 FR 23303
Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information; Draft Guidance for Industry; Availability; Federal Register Vol. 81, Issue
NOTICE
2016-09137
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2016-D-0973
4164-01-P
2016-09137
Notice of availability.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Comparability Protocols for Human Drugs and Biologics: Chemistry, Manufacturing, and Controls Information.'' This document is a revised version of a draft guidance that published in February 2003 entitled ``Comparability Protocols: Chemistry, Manufacturing, and Controls Information.'' A related draft guidance entitled ``Comparability Protocols--Protein Drug Products and Biological Products--Chemistry, Manufacturing, and Controls Information,'' that published in September 2003, was withdrawn on May 6, 2015. The revised draft guidance provides recommendations to human drug and biologics manufacturers on implementing a chemistry, manufacturing, and controls (CMC) postapproval change(s) through the use of a comparability protocol (CP). By using a CP, manufacturers who fall within the scope of this guidance will not have to submit commercial- scale CMC information on postchange products to FDA before making the proposed change. This draft guidance is intended to establish a framework to promote manufacturing of quality drug products.
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 June 20, 2016.
Stephen Moore, Center for Drug Evaluation and Research, Food and Drug Administration, Bldg. 21, Rm. 2012, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-7579 or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, Bldg. 71, Rm. 7268, 10903 New Hampshire Ave., Silver Spring, MD 20993- 0002, 240-402-7911.
Draft Guidance for Industry:
Comparability Protocols for Human Drugs and BiologicsChemistry, Manufacturing, and Controls Information
,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070305.pdf
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/QuestionsandAnswersonCurrentGoodManufacturingPracticescGMPforDrugs/UCM071836
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.fda.gov/scienceresearch/specialtopics/criticalpathinitiative/default.htm
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm073507.pdf
http://www.regulations.gov
Federal Register
Vol. 81, no. 76
Office of the Federal Register, National Archives and Records Administration
2016-04-20
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Table of Contents:
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https://www.govinfo.gov/app/details/FR-2016-04-20
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https://www.govinfo.gov/content/pkg/FR-2016-04-20/xml/FR-2016-04-20.xml
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