federal_register: 2011-27147
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 | regulation_id_numbers |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2011-27147 | International Conference on Harmonisation; E2B(R3) Electronic Transmission of Individual Case Safety Reports; Draft Guidance on Implementation; Data Elements and Message Specification; Appendix on Backwards and Forwards Compatibility; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs): Implementation Guide--Data Elements and Message Specification" (the draft E2B(R3) implementation guidance) and an appendix to the draft guidance entitled "ICSRs: Appendix to the Implementation Guide--Backwards and Forwards Compatibility" (the draft BFC appendix). The draft E2B(R3) implementation guidance and draft BFC appendix were prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft E2B(R3) implementation guidance is intended to revise the standards for submission of ICSRs and improve the inherent quality of the data, enabling improved handling and analysis of ICSR reports. The draft BFC appendix describes the relationship between data elements from the 2001 ICH E2B guidance and draft E2B(R3) implementation guidance. | 2011-10-20 | 2011 | 10 | https://www.federalregister.gov/documents/2011/10/20/2011-27147/international-conference-on-harmonisation-e2br3-electronic-transmission-of-individual-case-safety | https://www.govinfo.gov/content/pkg/FR-2011-10-20/pdf/2011-27147.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled "E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs): Implementation Guide--Data Elements and Message Specification" (the draft... |