federal_register: 2020-28560
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2020-28560 | Providing Regulatory Submissions in Electronic Format-Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling; Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Providing Regulatory Submissions in Electronic Format--Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling." This guidance is being issued in accordance with the Food and Drug Administration Safety and Innovation Act (FDASIA), which amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to require that certain submissions under the FD&C Act and the Public Health Service Act (PHS Act) be submitted in electronic format, beginning no earlier than 24 months after issuance of final guidance on electronic format for submissions. The guidance describes how FDA plans to implement the requirements for the electronic submission of Risk Evaluation and Mitigation Strategies (REMS) documents in certain submissions under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and certain biologics license applications (BLAs), beginning December 28, 2022. This guidance finalizes the draft guidance entitled "Providing Regulatory Submissions in Electronic Format--Content of the Risk Evaluation and Mitigation Strategies Document Using Structured Product Labeling" published September 5, 2017. | 2020-12-28 | 2020 | 12 | https://www.federalregister.gov/documents/2020/12/28/2020-28560/providing-regulatory-submissions-in-electronic-format-content-of-the-risk-evaluation-and-mitigation | https://www.govinfo.gov/content/pkg/FR-2020-12-28/pdf/2020-28560.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 "Providing Regulatory Submissions in Electronic Format--Content of the Risk Evaluation and Mitigation Strategies Document Using... |