federal_register: 03-30300
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 03-30300 | Amending the MedWatch Forms to Collect Postmarketing Adverse Event Data Relating to Race and Ethnicity | Notice | The Food and Drug Administration (FDA) is requesting comment on the advantages and disadvantages of systematically collecting race and ethnicity data in postmarketing adverse event reports. FDA is also seeking feedback on whether FDA's MedWatch forms (Forms 3500 and 3500A) should be amended to collect the race and ethnicity data. If the MedWatch forms are amended to collect race and ethnicity data, FDA would like comment on how the forms should be amended and the financial impact of amending the forms on both voluntary and mandatory reporters. FDA is also asking for comment on the implications that collecting such race and ethnicity data would have for international reporting of postmarketing adverse events. | 2003-12-08 | 2003 | 12 | https://www.federalregister.gov/documents/2003/12/08/03-30300/amending-the-medwatch-forms-to-collect-postmarketing-adverse-event-data-relating-to-race-and | https://www.govinfo.gov/content/pkg/FR-2003-12-08/pdf/03-30300.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is requesting comment on the advantages and disadvantages of systematically collecting race and ethnicity data in postmarketing adverse event reports. FDA is also seeking feedback on whether FDA's MedWatch forms... |