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Items: 1 to 20 of 136

1.

Impact of regulatory guidances and drug regulation on risk minimization interventions in drug safety: a systematic review.

Nkeng L, Cloutier AM, Craig C, Lelorier J, Moride Y.

Drug Saf. 2012 Jul 1;35(7):535-46. doi: 10.2165/11599720-000000000-00000. Review.

PMID:
22702638
2.

Safety-related regulatory actions for orphan drugs in the US and EU: a cohort study.

Heemstra HE, Giezen TJ, Mantel-Teeuwisse AK, de Vrueh RL, Leufkens HG.

Drug Saf. 2010 Feb 1;33(2):127-37. doi: 10.2165/11319870-000000000-00000.

PMID:
20082539
3.

Methodological gaps in the assessment of risk minimization interventions: a systematic review.

Gridchyna I, Cloutier AM, Nkeng L, Craig C, Frise S, Moride Y.

Pharmacoepidemiol Drug Saf. 2014 Jun;23(6):572-9. doi: 10.1002/pds.3596. Epub 2014 Feb 24. Review.

PMID:
24616240
4.

Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance.

Borg JJ, Aislaitner G, Pirozynski M, Mifsud S.

Drug Saf. 2011 Mar 1;34(3):187-97. doi: 10.2165/11586620-000000000-00000. Review.

PMID:
21332243
5.

Impact of safety-related regulatory action on clinical practice: a systematic review.

Piening S, Haaijer-Ruskamp FM, de Vries JT, van der Elst ME, de Graeff PA, Straus SM, Mol PG.

Drug Saf. 2012 May 1;35(5):373-85. doi: 10.2165/11599100-000000000-00000. Review.

PMID:
22480319
6.

Endovascular radiofrequency ablation for varicose veins: an evidence-based analysis.

Health Quality Ontario.

Ont Health Technol Assess Ser. 2011;11(1):1-93. Epub 2011 Feb 1.

7.

Prevention of falls and fall-related injuries in community-dwelling seniors: an evidence-based analysis.

Health Quality Ontario.

Ont Health Technol Assess Ser. 2008;8(2):1-78. Epub 2008 Oct 1.

8.

Endovascular laser therapy for varicose veins: an evidence-based analysis.

Health Quality Ontario.

Ont Health Technol Assess Ser. 2010;10(6):1-92. Epub 2010 Apr 1.

9.

Risk minimization activities of centrally authorized products in the EU: a descriptive study.

Zomerdijk IM, Sayed-Tabatabaei FA, Trifirò G, Blackburn SC, Sturkenboom MC, Straus SM.

Drug Saf. 2012 Apr 1;35(4):299-314. doi: 10.2165/11594560-000000000-00000.

PMID:
22339506
10.

The measurement and monitoring of surgical adverse events.

Bruce J, Russell EM, Mollison J, Krukowski ZH.

Health Technol Assess. 2001;5(22):1-194. Review.

11.

Patient-Reported Outcome Measures in Safety Event Reporting: PROSPER Consortium guidance.

Banerjee AK, Okun S, Edwards IR, Wicks P, Smith MY, Mayall SJ, Flamion B, Cleeland C, Basch E; Patient-Reported Outcomes Safety Event Reporting (PROSPER) Consortium.

Drug Saf. 2013 Dec;36(12):1129-49. doi: 10.1007/s40264-013-0113-z.

12.

Risk management in dermatology: an analysis of data available from several British-based reporting systems.

Gawkrodger DJ.

Br J Dermatol. 2011 Mar;164(3):537-43. doi: 10.1111/j.1365-2133.2010.10173.x. Epub 2011 Feb 7.

PMID:
21143464
13.

Suspected adverse drug reactions reported for children worldwide: an exploratory study using VigiBase.

Star K, Norén GN, Nordin K, Edwards IR.

Drug Saf. 2011 May 1;34(5):415-28. doi: 10.2165/11587540-000000000-00000.

PMID:
21513364
14.

Bariatric surgery: an evidence-based analysis.

Health Quality Ontario.

Ont Health Technol Assess Ser. 2005;5(1):1-148. Epub 2005 Jan 1.

15.

Provision of information on regulatory authorities' websites.

Vitry A, Lexchin J, Sasich L, Dupin-Spriet T, Reed T, Bertele V, Garattini S, Toop L, Hurley E.

Intern Med J. 2008 Jul;38(7):559-67. doi: 10.1111/j.1445-5994.2007.01588.x. Epub 2008 Mar 11.

PMID:
18336542
16.
17.

Natalizumab for relapsing remitting multiple sclerosis.

Pucci E, Giuliani G, Solari A, Simi S, Minozzi S, Di Pietrantonj C, Galea I.

Cochrane Database Syst Rev. 2011 Oct 5;(10):CD007621. doi: 10.1002/14651858.CD007621.pub2. Review.

PMID:
21975773
18.

European Medicines Agency assesses safety reporting at Roche.

Marshall H.

Lancet Oncol. 2012 Aug;13(8):e331. No abstract available.

PMID:
23024993
19.

A decade of safety-related regulatory action in the Netherlands: a retrospective analysis of direct healthcare professional communications from 1999 to 2009.

Mol PG, Straus SM, Piening S, de Vries JT, de Graeff PA, Haaijer-Ruskamp FM.

Drug Saf. 2010 Jun 1;33(6):463-74. doi: 10.2165/11532840-000000000-00000.

PMID:
20486729
20.

Sources of information used by regulatory agencies on the generation of drug safety alerts.

Alves C, Macedo AF, Marques FB.

Eur J Clin Pharmacol. 2013 Dec;69(12):2083-94. doi: 10.1007/s00228-013-1564-y. Epub 2013 Jul 27.

PMID:
23893047
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