federal_register: E8-30086
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| E8-30086 | Guidance for Industry on Diabetes Mellitus-Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Diabetes Mellitus-- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes." This guidance makes recommendations about how to demonstrate that a new antidiabetic therapy to treat type 2 diabetes is not associated with an unacceptable increase in cardiovascular risk. We are issuing this guidance for immediate implementation to ensure that relevant issues related to minimizing cardiovascular risk are considered by all sponsors who have ongoing drug development programs for type 2 diabetes. | 2008-12-19 | 2008 | 12 | https://www.federalregister.gov/documents/2008/12/19/E8-30086/guidance-for-industry-on-diabetes-mellitus-evaluating-cardiovascular-risk-in-new-antidiabetic | https://www.govinfo.gov/content/pkg/FR-2008-12-19/pdf/E8-30086.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Diabetes Mellitus-- Evaluating Cardiovascular Risk in New Antidiabetic Therapies to Treat Type 2 Diabetes." This guidance makes recommendations... |