These tools will no longer be maintained as of December 31, 2024. Archived website can be found here. PubMed4Hh GitHub repository can be found here. Contact NLM Customer Service if you have questions.
108 related articles for article (PubMed ID: 8074984)
41. International Conference on Harmonisation; guidance on Addendum to E2C Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs; availability. Notice. Food and Drug Administration, HHS Fed Regist; 2004 Feb; 69(24):5551-2. PubMed ID: 14968802 [TBL] [Abstract][Full Text] [Related]
42. Institutional review boards and approval of new products without human subjects research. Maloney DM Hum Res Rep; 2002 Jul; 17(7):1-2. PubMed ID: 12731489 [No Abstract] [Full Text] [Related]
43. Adventitious agents from animal-derived raw materials and production systems. Hellman KB; Honstead JP; Vincent CK Dev Biol Stand; 1996; 88():231-4. PubMed ID: 9119142 [No Abstract] [Full Text] [Related]
45. Human cells, tissues, and cellular and tissue-based products; donor screening and testing, and related labeling. Interim final rule; opportunity for public comment. Food and Drug Administration, HHS Fed Regist; 2005 May; 70(100):29949-52. PubMed ID: 15915582 [TBL] [Abstract][Full Text] [Related]
46. Overview: biological standardization in Europe and the USA. Løwenstein H Arb Paul Ehrlich Inst Bundesamt Sera Impfstoffe Frankf A M; 2003; (94):67-8; discussion 69. PubMed ID: 15119022 [No Abstract] [Full Text] [Related]
47. Current good manufacturing practices. Zuck TF Transfusion; 1995; 35(11):955-66. PubMed ID: 8604495 [No Abstract] [Full Text] [Related]
48. Revisions to the general safety requirements for biological products; companion document to direct final rule--FDA. Proposed rule. Fed Regist; 1998 Apr; 63(75):19431-4. PubMed ID: 10178870 [TBL] [Abstract][Full Text] [Related]
49. Human cells, tissues, and cellular and tissue-based products; establishment registration and listing. Food and Drug Administration, HHS. Final rule. Fed Regist; 2001 Jan; 66(13):5447-69. PubMed ID: 11503777 [TBL] [Abstract][Full Text] [Related]
50. Delegations of authority and organization; Office of the Commissioner--FDA. Final rule. Fed Regist; 1991 Nov; 56(225):58758. PubMed ID: 10115698 [TBL] [Abstract][Full Text] [Related]
51. The regulation of medicinal products derived from human blood or plasma in the European Community. Brunko P Dev Biol Stand; 1993; 81():269-71. PubMed ID: 8174813 [No Abstract] [Full Text] [Related]
52. Considerations in performing virus spiking experiments and process validation studies. Darling AJ Dev Biol Stand; 1993; 81():221-9. PubMed ID: 8174806 [TBL] [Abstract][Full Text] [Related]
53. Proposed approach to regulation of cellular and tissue-based products. The Food and Drug Administration. J Hematother; 1997 Jun; 6(3):195-212. PubMed ID: 9234175 [No Abstract] [Full Text] [Related]
54. The EEC and the regulation of blood derivatives. Horaud F Dev Biol Stand; 1993; 81():273-6. PubMed ID: 8174814 [No Abstract] [Full Text] [Related]
56. Delegations of authority and organization; Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, and Center for Drug Evaluation and Research--FDA. Final rule. Fed Regist; 1991 Nov; 56(225):58758-9. PubMed ID: 10115699 [TBL] [Abstract][Full Text] [Related]
57. "Come out, come out wherever you are": the Food and Drug Administration's proposed rule on establishment registration and listing for manufacturing of human cellular and tissue-based products. Minsk AG Tissue Eng; 1998; 4(4):445-6. PubMed ID: 9916175 [No Abstract] [Full Text] [Related]
58. Draft guidelines on compounding of nonsterile products in pharmacies. American Society of Hospital Pharmacists. Am J Hosp Pharm; 1993 Jul; 50(7):1452-61. PubMed ID: 8362883 [No Abstract] [Full Text] [Related]
59. Environmental assessment requirements for live biological drugs. Sutton A Clin Infect Dis; 2008 Feb; 46 Suppl 2():S112-4; discussion S144-51. PubMed ID: 18181713 [TBL] [Abstract][Full Text] [Related]
60. WHO activities to assure the quality of biological products. Magrath D Dev Biol Stand; 1993; 81():265-8. PubMed ID: 8174812 [No Abstract] [Full Text] [Related] [Previous] [Next] [New Search]