federal_register: 2010-29927
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2010-29927 | Clinical Development Programs for Sedation Products; Request for Assistance | Notice | The Food and Drug Administration (FDA) is seeking information on a variety of issues related to the clinical development and use of sedation products in adult and pediatric age groups. FDA is inviting any interested party, or parties, to facilitate an evaluation of critical fundamentals of the science related to sedation products by conducting and managing a coordination of activities that will bring together experts in the field, including from academia, patient organizations, and industry. The first step in this process would be for the party or parties to plan and hold one or more public meetings to discuss these issues. FDA intends to take into account the information provided from these activities as we develop FDA guidance on clinical development programs for sedation products. We intend to submit to the docket all the information received in response to this notice so that interested parties may be fully informed. | 2010-11-29 | 2010 | 11 | https://www.federalregister.gov/documents/2010/11/29/2010-29927/clinical-development-programs-for-sedation-products-request-for-assistance | https://www.govinfo.gov/content/pkg/FR-2010-11-29/pdf/2010-29927.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is seeking information on a variety of issues related to the clinical development and use of sedation products in adult and pediatric age groups. FDA is inviting any interested party, or parties, to facilitate an... |