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2013-05-31
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New Approaches to Antibacterial Drug Development; Request for Comments
Notices
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D09002ee1bdca27a2
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's (FDA) Center for Drug Evaluation and Research (CDER) is seeking input from the public on the following topics related to antibacterial drug development: Potential new study designs, proposed priorities for CDER guidances, and strategies intended to slow the rate of emerging resistance to antibacterial drugs. The purpose of this notice is to request information and comments from the public on these areas of focus.
78 FR 32669
https://www.govinfo.gov/app/details/FR-2013-05-31/2013-12925
2013-12925
fr31my13-60
4160-01-P
Docket No. FDA-2013-N-0556
https://www.govinfo.gov/app/details/FR-2013-05-31/2013-12925
https://www.govinfo.gov/content/pkg/FR-2013-05-31/html/2013-12925.htm
https://www.govinfo.gov/content/pkg/FR-2013-05-31/pdf/2013-12925.pdf
2 p.
32669
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78 FR 32669
New Approaches to Antibacterial Drug Development; Request for Comments; Federal Register Vol. 78, Issue
NOTICE
2013-12925
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
2013-07-30
Docket No. FDA-2013-N-0556
4160-01-P
2013-12925
Notice; request for comments.
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) is seeking input from the public on the following topics related to antibacterial drug development: Potential new study designs, proposed priorities for CDER guidances, and strategies intended to slow the rate of emerging resistance to antibacterial drugs. The purpose of this notice is to request information and comments from the public on these areas of focus.
Submit either electronic or written comments by July 30, 2013 at 5 p.m. EST.
Jonas Santiago, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, 301-796-5346, FAX: 301- 847-3529, email: jonas.santiago@fda.hhs.gov.
New Approaches to Antibacterial Drug Development
,
jonas.santiago@fda.hhs.gov
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070981.pdf
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM234907.pdf
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM321390.pdf
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm320643.htm
http://www.regulations.gov
Federal Register
Vol. 78, no. 105
Office of the Federal Register, National Archives and Records Administration
2013-05-31
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https://www.govinfo.gov/app/details/FR-2013-05-31
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https://www.govinfo.gov/app/details/FR-2013-05-31
https://www.govinfo.gov/content/pkg/FR-2013-05-31/pdf/FR-2013-05-31.pdf
https://www.govinfo.gov/content/pkg/FR-2013-05-31/xml/FR-2013-05-31.xml
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