federal_register: 2013-19962
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2013-19962 | Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and Product Management To Reduce the Risk of Transfusion-Transmitted Malaria; Availability | Notice | The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria" dated August 2013. The guidance document provides blood establishments that collect blood and blood components with recommendations for questioning and deferring donors of blood and blood components, allowing their reentry, and product management to reduce the risk of transfusion-transmitted malaria. This guidance finalizes the draft guidance of the same title dated June 2012, and supersedes the FDA memorandum to all registered blood establishments entitled "Recommendations for Deferral of Donors for Malaria Risk" dated July 26, 1994. The recommendations contained in the guidance are not applicable to donors of Source Plasma. | 2013-08-19 | 2013 | 8 | https://www.federalregister.gov/documents/2013/08/19/2013-19962/guidance-for-industry-recommendations-for-donor-questioning-deferral-reentry-and-product-management | https://www.govinfo.gov/content/pkg/FR-2013-08-19/pdf/2013-19962.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA) is announcing the availability of a document entitled "Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria"... |