federal_register: 2024-22562
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
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| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024-22562 | Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers; Guidance for Industry; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers." The guidance provides information for sponsors, clinical investigators, institutional review boards (IRBs), contract research organizations (CROs), and other interested parties on the use of electronic systems, electronic records, and electronic signatures in clinical investigations of foods, medical products, tobacco products, and new animal drugs. The guidance provides recommendations regarding the requirements in our regulations, pursuant to which FDA considers electronic systems, electronic records, and electronic signatures to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. This guidance finalizes the draft guidance of the same title issued on March 16, 2023, and supersedes the guidance for industry entitled "Computerized Systems Used in Clinical Investigations" issued in May 2007. | 2024-10-02 | 2024 | 10 | https://www.federalregister.gov/documents/2024/10/02/2024-22562/electronic-systems-electronic-records-and-electronic-signatures-in-clinical-investigations-questions | https://www.govinfo.gov/content/pkg/FR-2024-10-02/pdf/2024-22562.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 "Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations: Questions and Answers." The... |