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2010-09-23
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Draft Guidance for Industry on Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention; Availability
Notices
D09002ee1bdd96079
D09002ee1bdd960f2
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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention.'' The draft guidance provides recommendations for industry for developing drugs and therapeutic biologics for the prevention and treatment of diabetes mellitus. Because diabetes mellitus has reached epidemic proportions in the United States, FDA recognizes the need for new products that can be used as part of a comprehensive treatment strategy in the treatment and prevention of diabetes. In addition to the draft guidance, FDA plans to convene a public advisory committee meeting to specifically discuss new approaches for the development of products for the treatment of diabetes, with particular emphasis on the design and implementation of studies to assess long-term cardiovascular risks and benefits of these new products. FDA plans to announce the meeting date in a future issue of the Federal Register.
73 FR 11420
https://www.govinfo.gov/app/details/FR-2008-03-03/E8-3974
E8-3974
fr03mr08-59
4160-01-S
Docket No. FDA-2008-D-0118
https://www.govinfo.gov/app/details/FR-2008-03-03/E8-3974
https://www.govinfo.gov/content/pkg/FR-2008-03-03/html/E8-3974.htm
https://www.govinfo.gov/content/pkg/FR-2008-03-03/pdf/E8-3974.pdf
1 p.
11420
11420
73 FR 11420
Draft Guidance for Industry on Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention; Availability; Federal Register Vol. 73, Issue
NOTICE
E8-3974
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2008-D-0118
4160-01-S
E8-3974
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention.'' The draft guidance provides recommendations for industry for developing drugs and therapeutic biologics for the prevention and treatment of diabetes mellitus. Because diabetes mellitus has reached epidemic proportions in the United States, FDA recognizes the need for new products that can be used as part of a comprehensive treatment strategy in the treatment and prevention of diabetes. In addition to the draft guidance, FDA plans to convene a public advisory committee meeting to specifically discuss new approaches for the development of products for the treatment of diabetes, with particular emphasis on the design and implementation of studies to assess long-term cardiovascular risks and benefits of these new products. FDA plans to announce the meeting date in a future issue of the Federal Register.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by May 2, 2008.
Ilan Irony, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 3100, Silver Spring, MD 20993-0002, 301-796-2290.
Draft Guidance for Industry:
Diabetes Mellitus; Developing Drugs and Therapeutic Biologics for Treatment and Prevention,
http://www.fda.gov/cder/guidance/index.htm
http://www.fda.gov/ohrms/dockets/default.htm
http://www.regulations.gov
Federal Register
Vol. 73, no. 42
Office of the Federal Register, National Archives and Records Administration
2008-03-03
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224 p.
Table of Contents:
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https://www.govinfo.gov/app/details/FR-2008-03-03
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https://www.govinfo.gov/app/details/FR-2008-03-03
https://www.govinfo.gov/content/pkg/FR-2008-03-03/pdf/FR-2008-03-03.pdf
https://www.govinfo.gov/content/pkg/FR-2008-03-03/xml/FR-2008-03-03.xml
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2010-09-23
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