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2. Letter to manufacturers of blood establishment computer software products--FDA. Notice. Fed Regist; 1994 Aug; 59(168):44991-2. PubMed ID: 10136917 [TBL] [Abstract][Full Text] [Related]
3. Patient safety or profit: what incentives are blood shield laws and FDA regulations creating for the tissue banking industry? Williams JL Indiana Health Law Rev; 2005; 2(1):295-328. PubMed ID: 17111505 [No Abstract] [Full Text] [Related]
4. FDA NPRM would standardize blood labeling to permit inventory automation. McNeal BM Health Law Vigil; 1980 Dec; 3(24):6-7. PubMed ID: 10248995 [No Abstract] [Full Text] [Related]
8. FDA & clinical software vendors: a line in the sand? Schneider P Healthc Inform; 1996 Jun; 13(6):100-2, 104, 106. PubMed ID: 10161397 [No Abstract] [Full Text] [Related]
9. Progress in blood supply safety. Revelle M FDA Consum; 1995 Apr; 29(3):21-4. PubMed ID: 10141840 [No Abstract] [Full Text] [Related]
10. Impending FDA regulations of healthcare software. First stop: blood banking. Interview by Bill W. Childs. Marrazzo J US Healthc; 1988 Nov; 5(11):17-8. PubMed ID: 10291018 [No Abstract] [Full Text] [Related]
11. Cross-referencing of ISO-9000 and regulatory quality systems at blood centers. Healy-Collier K Top Health Inf Manage; 1998 May; 18(4):32-8. PubMed ID: 10179274 [TBL] [Abstract][Full Text] [Related]
12. Controversies in transfusion medicine. Blood banks should use good manufacturing practices and the pharmaceutical manufacturing approach [corrected]. Miller WV Transfusion; 1993 May; 33(5):435-8. PubMed ID: 8488549 [No Abstract] [Full Text] [Related]
13. Food and Drug Administration regulation of blood bank software: the new regulatory landscape for blood establishments and their vendors. Weeda DF; O'Flaherty NF Transfusion; 1998 Jan; 38(1):86-9. PubMed ID: 9482400 [No Abstract] [Full Text] [Related]
14. Hepatitis C screening and notification: hospitals under new FDA regulations. Thomas M; Favata-Bosh DM QRC Advis; 1999 Jan; 15(3):1-5. PubMed ID: 10345516 [No Abstract] [Full Text] [Related]
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17. International Conference on Harmonisation; guidance on good manufacturing practice for active pharmaceutical ingredients; availability. Notice. Food and Drug Administration, HHS Fed Regist; 2001 Sep; 66(186):49028-9. PubMed ID: 12358036 [TBL] [Abstract][Full Text] [Related]
18. Medical device software regulation: an industry perspective. Simons D Food Drug Law J; 1997; 52(2):189-92. PubMed ID: 10557558 [No Abstract] [Full Text] [Related]
19. Revisions to the requirements applicable to blood, blood components, and source plasma. Final rule. Food and Drug Administration, HHS Fed Regist; 2001 Aug; 66(151):40886-90. PubMed ID: 11732557 [TBL] [Abstract][Full Text] [Related]
20. Pressure grows over US blood ban. Goodman S Nature; 2001 Aug; 412(6846):467. PubMed ID: 11484010 [No Abstract] [Full Text] [Related] [Next] [New Search]