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2016-06-04
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Labeling for Biosimilar Products; Draft Guidance for Industry; Availability; Extension of Comment Period
Notices
D09002ee1bdc1a8d6
D09002ee1bdc1a95a
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(FDA or Agency) is extending the comment period for the notice entitled ``Labeling for Biosimilar Products; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of April 4, 2016. The Agency is taking this action to allow interested persons additional time to submit comments.
81 FR 36313
https://www.govinfo.gov/app/details/FR-2016-06-06/2016-13223
2016-13223
fr06jn16-81
4164-01-P
Docket No. FDA-2016-D-0643
https://www.govinfo.gov/app/details/FR-2016-06-06/2016-13223
https://www.govinfo.gov/content/pkg/FR-2016-06-06/html/2016-13223.htm
https://www.govinfo.gov/content/pkg/FR-2016-06-06/pdf/2016-13223.pdf
2 p.
36313
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81 FR 36313
Labeling for Biosimilar Products; Draft Guidance for Industry; Availability; Extension of Comment Period; Federal Register Vol. 81, Issue
NOTICE
2016-13223
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2016-08-02
Docket No. FDA-2016-D-0643
4164-01-P
2016-13223
Notice of availability; extension of comment period.
The Food and Drug Administration (FDA or Agency) is extending the comment period for the notice entitled ``Labeling for Biosimilar Products; Draft Guidance for Industry; Availability'' that appeared in the Federal Register of April 4, 2016. The Agency is taking this action to allow interested persons additional time to submit comments.
FDA is extending the comment period for the notice that published on April 4, 2016 (81 FR 19194) by an additional 60 days. Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to permit the Agency to consider your comments before issuing the final version of the guidance, submit either electronic or written comments on the draft guidance by August 2, 2016.
Sandra Benton, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6340, Silver Spring, MD 20993-0002, 301- 796-1042; 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.
Guidance:
Labeling for Biosimilar Products; Extension of Comment Period
,
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm
http://www.fda.gov/regulatoryinformation/dockets/default.htm
http://www.regulations.gov
Federal Register
Vol. 81, no. 108
Office of the Federal Register, National Archives and Records Administration
2016-06-06
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304 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-2016-06-06
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https://www.govinfo.gov/app/details/FR-2016-06-06
https://www.govinfo.gov/content/pkg/FR-2016-06-06/pdf/FR-2016-06-06.pdf
https://www.govinfo.gov/content/pkg/FR-2016-06-06/xml/FR-2016-06-06.xml
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