federal_register: E8-3974
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| E8-3974 | Draft Guidance for Industry on Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention." The draft guidance provides recommendations for industry for developing drugs and therapeutic biologics for the prevention and treatment of diabetes mellitus.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 In addition to the draft guidance, FDA plans to convene a public advisory committee meeting to specifically discuss new approaches for the development of products for the treatment of diabetes,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. | 2008-03-03 | 2008 | 3 | https://www.federalregister.gov/documents/2008/03/03/E8-3974/draft-guidance-for-industry-on-diabetes-mellitus-developing-drugs-and-therapeutic-biologics-for | https://www.govinfo.gov/content/pkg/FR-2008-03-03/pdf/E8-3974.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled "Diabetes Mellitus: Developing Drugs and Therapeutic Biologics for Treatment and Prevention." The draft guidance provides recommendations... |