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2013-11-27
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Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate; Reopening of the Comment Period
Notices
D09002ee1bdc8ce86
D09002ee1bdc8cf1c
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The Food and Drug Administration (FDA) is reopening the comment period for the notice of availability entitled ``Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate'', published in the Federal Register of September 10, 2013 (78 FR 55263). In that notice, FDA requested public comment on the draft guidance. FDA is reopening the comment period due to the inability of some commenters to submit comments through the www.regulations.gov Web site from November 4, 2013, through November 13, 2013, due to technical difficulties.
78 FR 70953
https://www.govinfo.gov/app/details/FR-2013-11-27/2013-28394
2013-28394
fr27no13-70
4160-01-P
Docket No. FDA-2007-D-0369
https://www.govinfo.gov/app/details/FR-2013-11-27/2013-28394
https://www.govinfo.gov/content/pkg/FR-2013-11-27/html/2013-28394.htm
https://www.govinfo.gov/content/pkg/FR-2013-11-27/pdf/2013-28394.pdf
1 p.
70953
70953
78 FR 70953
Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate; Reopening of the Comment Period; Federal Register Vol. 78, Issue
NOTICE
2013-28394
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2013-12-11
Docket No. FDA-2007-D-0369
4160-01-P
2013-28394
Notice; reopening of the comment period.
The Food and Drug Administration (FDA) is reopening the comment period for the notice of availability entitled ``Draft Guidance for Industry on Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate'', published in the Federal Register of September 10, 2013 (78 FR 55263). In that notice, FDA requested public comment on the draft guidance. FDA is reopening the comment period due to the inability of some commenters to submit comments through the www.regulations.gov Web site from November 4, 2013, through November 13, 2013, due to technical difficulties.
Submit either electronic or written comments to the docket by December 11, 2013.
Bhawana Saluja, Center for Drug Evaluation and Research (HFD-643), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-276-8465.
Draft Guidance for Industry:
Bioequivalence Recommendations for Fluticasone Propionate; Salmeterol Xinafoate
,
http://www.regulations.gov
www.regulations.gov
Federal Register
Vol. 78, no. 229
Office of the Federal Register, National Archives and Records Administration
2013-11-27
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596 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2013-11-27
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https://www.govinfo.gov/app/details/FR-2013-11-27
https://www.govinfo.gov/content/pkg/FR-2013-11-27/pdf/FR-2013-11-27.pdf
https://www.govinfo.gov/content/pkg/FR-2013-11-27/xml/FR-2013-11-27.xml
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