federal_register: E8-30061
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| E8-30061 | Clinical Studies of Safety and Effectiveness of Orphan Products | Notice | The Food and Drug Administration's (FDA) Office of Orphan Product Development (OPD) is providing notice of a funding opportunity announcement for Federal assistance. The goal of the OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. | 2008-12-18 | 2008 | 12 | https://www.federalregister.gov/documents/2008/12/18/E8-30061/clinical-studies-of-safety-and-effectiveness-of-orphan-products | https://www.govinfo.gov/content/pkg/FR-2008-12-18/pdf/E8-30061.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration's (FDA) Office of Orphan Product Development (OPD) is providing notice of a funding opportunity announcement for Federal assistance. The goal of the OPD grant program is to support the clinical development of products... |