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Items: 1 to 20 of 21

1.
2.

Quality assessment of spontaneous triggered adverse event reports received by the Food and Drug Administration.

Brajovic S, Piazza-Hepp T, Swartz L, Dal Pan G.

Pharmacoepidemiol Drug Saf. 2012 Jun;21(6):565-70; discussion 571-2. doi: 10.1002/pds.3223. Epub 2012 Feb 22. Review.

PMID:
22359404
3.

Topical bovine thrombin: a 21-year review of topical bovine thrombin spontaneous case safety reports submitted to FDA's Adverse Event Reporting System.

Clark JA, Humphries JE, Crean S, Reynolds MW.

Pharmacoepidemiol Drug Saf. 2010 Feb;19(2):107-14. doi: 10.1002/pds.1874. Review.

PMID:
20014051
4.

Finding, evaluating, and managing drug-related risks: approaches taken by the US Food and Drug Administration (FDA).

Weaver J, Grenade LL, Kwon H, Avigan M.

Dermatol Ther. 2009 May-Jun;22(3):204-15. doi: 10.1111/j.1529-8019.2009.01233.x. Review.

PMID:
19453344
5.

[Adverse drug reaction surveillance system in Korea].

Choi NK, Park BJ.

J Prev Med Public Health. 2007 Jul;40(4):278-84. Review. Korean.

PMID:
17693730
6.
7.

Role of postmarketing surveillance in contemporary medicine.

Woodcock J, Behrman RE, Dal Pan GJ.

Annu Rev Med. 2011;62:1-10. doi: 10.1146/annurev-med-060309-164311. Review.

PMID:
20809798
8.

Limitations and strengths of spontaneous reports data.

Goldman SA.

Clin Ther. 1998;20 Suppl C:C40-4. Review.

PMID:
9915089
9.

Original research: Intravenous ribavirin--review of the FDA's Emergency Investigational New Drug Database (1997-2008) and literature review.

Riner A, Chan-Tack KM, Murray JS.

Postgrad Med. 2009 May;121(3):139-46. doi: 10.3810/pgm.2009.05.2014. Review.

PMID:
19491552
10.

The state of dietary supplement adverse event reporting in the United States.

Gardiner P, Sarma DN, Low Dog T, Barrett ML, Chavez ML, Ko R, Mahady GB, Marles RJ, Pellicore LS, Giancaspro GI.

Pharmacoepidemiol Drug Saf. 2008 Oct;17(10):962-70. doi: 10.1002/pds.1627. Review.

PMID:
18613260
11.
12.

[FDA's new drug approval system].

Ishii A.

Gan To Kagaku Ryoho. 1995 Aug;22(9):1146-51. Review. Japanese. No abstract available.

PMID:
7661565
13.

Adverse event monitoring and multivitamin-multimineral dietary supplements.

Woo JJ.

Am J Clin Nutr. 2007 Jan;85(1):323S-324S. Review.

14.

The safety of niacin in the US Food and Drug Administration adverse event reporting database.

Alsheikh-Ali AA, Karas RH.

Am J Cardiol. 2008 Apr 17;101(8A):9B-13B. doi: 10.1016/j.amjcard.2008.02.027. Review.

PMID:
18375244
15.

Informatic tools and approaches in postmarketing pharmacovigilance used by FDA.

Weaver J, Willy M, Avigan M.

AAPS J. 2008;10(1):35-41. doi: 10.1208/s12248-007-9004-5. Epub 2008 Jan 25. Review.

16.

Reporting of deaths during pre-approval clinical trials for advanced HIV-infected populations.

Johann-Liang R, James AN, Behr VL, Struble K, Birnkrant DB.

Drug Saf. 2005;28(7):559-64. Review.

PMID:
15963004
17.

FDA Safety Reviews on Drugs, Biologics, and Vaccines: 2007-2013.

Cope JU, Rosenthal GL, Weinel P, Odegaard A, Murphy DM.

Pediatrics. 2015 Dec;136(6):1125-31. doi: 10.1542/peds.2015-0469. Review.

PMID:
26598453
18.

Evidence behind FDA alerts for drugs with adverse cardiovascular effects: implications for clinical practice.

Rackham DM, C Herink M, Stevens IG, Cardoza NM, Singh H.

Pharmacotherapy. 2014;34(4):358-72. doi: 10.1002/phar.1381. Epub 2013 Dec 18. Review.

PMID:
24347043
19.

The way towards adverse event monitoring in clinical trials.

Wallander MA.

Drug Saf. 1993 Mar;8(3):251-62. Review.

PMID:
8452665
20.

Ethical and Scientific Issues in Studying the Safety of Approved Drugs.

Committee on Ethical and Scientific Issues in Studying the Safety of Approved Drugs, Board on Population Health and Public Health Practice, Institute of Medicine.

Washington (DC): National Academies Press (US); 2012 May 01.

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