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2011-08-04
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Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability
Notices
D09002ee1bdcfce0d
D09002ee1bdcfceab
United States
Department of Health and Human Services
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org
United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
Under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), the Food and Drug Administration (FDA) is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct.
76 FR 47211
https://www.govinfo.gov/app/details/FR-2011-08-04/2011-19806
2011-19806
fr04au11-67
4160-01-P
Docket No. FDA-2011-N-0332
https://www.govinfo.gov/app/details/FR-2011-08-04/2011-19806
https://www.govinfo.gov/content/pkg/FR-2011-08-04/html/2011-19806.htm
https://www.govinfo.gov/content/pkg/FR-2011-08-04/pdf/2011-19806.pdf
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76 FR 47211
Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability; Federal Register Vol. 76, Issue
NOTICE
2011-19806
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2011-N-0332
4160-01-P
2011-19806
Notice of availability.
Under the Food and Drug Administration Modernization Act of 1997 (Modernization Act), the Food and Drug Administration (FDA) is required to report annually in the Federal Register on the status of postmarketing requirements and commitments required of, or agreed upon by, holders of approved drug and biological products. This notice is the Agency's report on the status of the studies and clinical trials that applicants have agreed to, or are required to, conduct.
Beth Duvall-Miller, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 6466, Silver Spring, MD 20993-0002, 301- 796-0700; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1400 Rockville Pike, Rockville, MD 20852, 301-827-6210.
Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments; Availability
,
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Post-marketingPhaseIVCommitments/default.htm
Federal Register
Vol. 76, no. 150
Office of the Federal Register, National Archives and Records Administration
2011-08-04
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376 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
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https://www.govinfo.gov/app/details/FR-2011-08-04
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https://www.govinfo.gov/app/details/FR-2011-08-04
https://www.govinfo.gov/content/pkg/FR-2011-08-04/pdf/FR-2011-08-04.pdf
https://www.govinfo.gov/content/pkg/FR-2011-08-04/xml/FR-2011-08-04.xml
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