268 related articles for article (PubMed ID: 19174063)
1. [First-in-human clinical trials: comparison of EMEA and FDA guidelines].
Hernández-López C
Med Clin (Barc); 2009 Jan; 132(1):30-4. PubMed ID: 19174063
[No Abstract] [Full Text] [Related]
2. The EMEA guideline on first-in-human clinical trials and its impact on pharmaceutical development.
Milton MN; Horvath CJ
Toxicol Pathol; 2009 Apr; 37(3):363-71. PubMed ID: 19246571
[No Abstract] [Full Text] [Related]
3. Patient-reported outcomes: assessment and current perspectives of the guidelines of the Food and Drug Administration and the reflection paper of the European Medicines Agency.
Bottomley A; Jones D; Claassens L
Eur J Cancer; 2009 Feb; 45(3):347-53. PubMed ID: 19013787
[TBL] [Abstract][Full Text] [Related]
4. The impact of FDA and EMEA guidelines on drug development in relation to Phase 0 trials.
Marchetti S; Schellens JH
Br J Cancer; 2007 Sep; 97(5):577-81. PubMed ID: 17726450
[TBL] [Abstract][Full Text] [Related]
5. New clinical trials policy at FDA.
Vastag B
Nat Biotechnol; 2006 Sep; 24(9):1043. PubMed ID: 16964196
[No Abstract] [Full Text] [Related]
6. Researchers and regulators reflect on first gene therapy death.
Hollon T
Nat Med; 2000 Jan; 6(1):6. PubMed ID: 10613797
[No Abstract] [Full Text] [Related]
7. FDA tightens human oversight.
Dove A
Nat Med; 2001 Jun; 7(6):646. PubMed ID: 11385485
[No Abstract] [Full Text] [Related]
8. SNM submits imaging endpoint comments to FDA.
Clarke B; Merrill J
J Nucl Med; 2012 Feb; 53(2):13N. PubMed ID: 22302969
[No Abstract] [Full Text] [Related]
9. FDA insists on more women in drug trials.
Josefson D
BMJ; 1997 Oct; 315(7112):833. PubMed ID: 9353497
[No Abstract] [Full Text] [Related]
10. FDA issues guidance on race and ethnicity data.
Meadows M
FDA Consum; 2003; 37(3):36. PubMed ID: 12793392
[No Abstract] [Full Text] [Related]
11. FDA. Proposed guidelines for emergency research aim to quell confusion.
Couzin J
Science; 2006 Sep; 313(5792):1372-3. PubMed ID: 16959979
[No Abstract] [Full Text] [Related]
12. [Introduction and consideration of the anti-cancer drug evaluation strategy in Europe and America].
Tang JY; Ma L; Zhang L
Zhonghua Zhong Liu Za Zhi; 2008 Oct; 30(10):798-800. PubMed ID: 19173820
[No Abstract] [Full Text] [Related]
13. FDA tells senators of doctors who fake data in clinical drug trials.
Holden C
Science; 1979 Oct; 206(4417):423-3. PubMed ID: 504984
[No Abstract] [Full Text] [Related]
14. [Europe 1992: big brother is watching you].
Offerhaus L
Ned Tijdschr Geneeskd; 1989 Oct; 133(43):2111-2. PubMed ID: 2812101
[No Abstract] [Full Text] [Related]
15. FDA gene rules impractical.
Morrison C
Nat Biotechnol; 2001 Jan; 19(1):5. PubMed ID: 11135515
[No Abstract] [Full Text] [Related]
16. Lost in translation: differences in antimicrobial indication approval policies between the United States and Europe.
Pappas G; Ierodiakonou V; Falagas ME
Clin Ther; 2009 Jul; 31(7):1595-603. PubMed ID: 19695409
[TBL] [Abstract][Full Text] [Related]
17. Bioanalytical method validation: notable points in the 2009 draft EMA Guideline and differences with the 2001 FDA Guidance.
Smith G
Bioanalysis; 2010 May; 2(5):929-35. PubMed ID: 21083222
[No Abstract] [Full Text] [Related]
18. Time to adapt.
Nature; 2010 Apr; 464(7293):1245-6. PubMed ID: 20428115
[No Abstract] [Full Text] [Related]
19. FDA regulation of stem cell-based products.
Fink DW
Science; 2009 Jun; 324(5935):1662-3. PubMed ID: 19556496
[TBL] [Abstract][Full Text] [Related]
20. Diabetes trial stirs debate on safety of xenotransplants.
Check E
Nature; 2002 Sep; 419(6902):5. PubMed ID: 12214198
[No Abstract] [Full Text] [Related]
[Next] [New Search]