United States Government Publishing Office
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2020-12-17
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Controlled Correspondence Related to Generic Drug Development; Guidance for Industry; Availability
Notices
D09002ee1bdb31a80
D09002ee1bdb31af5
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 or Agency) is announcing the availability of a final guidance for industry entitled ``Controlled Correspondence Related to Generic Drug Development.'' This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency's process for providing communications related to such correspondence. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA's controlled correspondence response and the Agency's process for responding to those requests. This guidance finalizes the draft guidance announced in the Federal Register on November 3, 2017, and replaces the guidance for industry ``Controlled Correspondence Related to Generic Drug Development'' issued in September 2015.
85 FR 81928
https://www.govinfo.gov/app/details/FR-2020-12-17/2020-27810
2020-27810
fr17de20-53
4164-01-P
Docket No. FDA-2014-D-1167
https://www.govinfo.gov/app/details/FR-2020-12-17/2020-27810
https://www.govinfo.gov/content/pkg/FR-2020-12-17/html/2020-27810.htm
https://www.govinfo.gov/content/pkg/FR-2020-12-17/pdf/2020-27810.pdf
2 p.
81928
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85 FR 81928
Controlled Correspondence Related to Generic Drug Development; Guidance for Industry; Availability; Federal Register Vol. 85, Issue
NOTICE
2020-27810
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2014-D-1167
4164-01-P
2020-27810
Notice of availability.
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled ``Controlled Correspondence Related to Generic Drug Development.'' This guidance provides information regarding the process by which generic drug manufacturers and related industry can submit controlled correspondence to FDA requesting information related to generic drug development and the Agency's process for providing communications related to such correspondence. This guidance also describes the process by which generic drug manufacturers and related industry can submit requests to clarify ambiguities in FDA's controlled correspondence response and the Agency's process for responding to those requests. This guidance finalizes the draft guidance announced in the Federal Register on November 3, 2017, and replaces the guidance for industry ``Controlled Correspondence Related to Generic Drug Development'' issued in September 2015.
The announcement of the guidance is published in the Federal Register on December 17, 2020.
Lisa Bercu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 240-402-6902.
Guidance:
Controlled Correspondence Related to Generic Drug Development,
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf
https://www.regulations.gov
Federal Register
Vol. 85, no. 243
Office of the Federal Register, National Archives and Records Administration
2020-12-17
continuing
daily
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525 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2020-12-17
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https://www.govinfo.gov/app/details/FR-2020-12-17
https://www.govinfo.gov/content/pkg/FR-2020-12-17/pdf/FR-2020-12-17.pdf
https://www.govinfo.gov/content/pkg/FR-2020-12-17/xml/FR-2020-12-17.xml
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2020-12-17
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FR-2020-12-17
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FR-2020-12-17
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