federal_register: 2023-28092
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2023-28092 | Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization; Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization." This guidance provides recommendations to sponsors on the development of monoclonal antibody products targeting SARS-CoV-2 intended for the prevention or treatment of COVID- 19, including addressing the impact of emerging variants. The recommendations focus on the data and information that may be used to support a request for emergency use authorization (EUA) under the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance supersedes the guidance entitled "Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants, During the COVID-19 Public Health Emergency" issued on February 22, 2021. | 2023-12-21 | 2023 | 12 | https://www.federalregister.gov/documents/2023/12/21/2023-28092/development-of-monoclonal-antibody-products-targeting-sars-cov-2-for-emergency-use-authorization | https://www.govinfo.gov/content/pkg/FR-2023-12-21/pdf/2023-28092.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Development of Monoclonal Antibody Products Targeting SARS-CoV-2 for Emergency Use Authorization." This guidance provides... |