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Items: 1 to 20 of 471

1.

Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European Public Assessment Reports.

Arnardottir AH, Haaijer-Ruskamp FM, Straus SM, de Graeff PA, Mol PG.

Drug Saf. 2011 Nov 1;34(11):1101-14. doi: 10.2165/11592060-000000000-00000.

PMID:
21981437
2.

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
3.

Additional safety risk to exceptionally approved drugs in Europe?

Arnardottir AH, Haaijer-Ruskamp FM, Straus SM, Eichler HG, de Graeff PA, Mol PG.

Br J Clin Pharmacol. 2011 Sep;72(3):490-9. doi: 10.1111/j.1365-2125.2011.03995.x.

4.

Post-approval safety issues with innovative drugs: a European cohort study.

Mol PG, Arnardottir AH, Motola D, Vrijlandt PJ, Duijnhoven RG, Haaijer-Ruskamp FM, de Graeff PA, Denig P, Straus SM.

Drug Saf. 2013 Nov;36(11):1105-15. doi: 10.1007/s40264-013-0094-y.

PMID:
24048690
5.

Information for adequate prescribing to older patients : an evaluation of the product information of 53 recently approved medicines.

Beers E, Egberts TC, Leufkens HG, Jansen PA.

Drugs Aging. 2013 Apr;30(4):255-62. doi: 10.1007/s40266-013-0059-y.

PMID:
23420118
6.

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
7.

Inconsistencies among European Union pharmaceutical regulator safety communications: a cross-country comparison.

Zeitoun JD, Lefèvre JH, Downing N, Bergeron H, Ross JS.

PLoS One. 2014 Oct 21;9(10):e109100. doi: 10.1371/journal.pone.0109100.

8.

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
9.

New antirheumatic drugs: any real added value? A critical overview of regulatory criteria for their marketing approval.

Bertele' V, Assisi A, Di Muzio V, Renzo D, Garattini S.

Eur J Clin Pharmacol. 2007 Sep;63(9):879-89.

PMID:
17646975
10.

Regulatory review time and post-market safety events for novel medicines approved by the EMA between 2001 and 2010: a cross-sectional study.

Zeitoun JD, Lefèvre JH, Downing NS, Bergeron H, Ross JS.

Br J Clin Pharmacol. 2015 Oct;80(4):716-26. doi: 10.1111/bcp.12643.

11.

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
12.

Safety-related regulatory actions for biologicals approved in the United States and the European Union.

Giezen TJ, Mantel-Teeuwisse AK, Straus SM, Schellekens H, Leufkens HG, Egberts AC.

JAMA. 2008 Oct 22;300(16):1887-96. doi: 10.1001/jama.300.16.1887.

PMID:
18940975
13.

Pharmacovigilance during the pre-approval phases: an evolving pharmaceutical industry model in response to ICH E2E, CIOMS VI, FDA and EMEA/CHMP risk-management guidelines.

Hartford CG, Petchel KS, Mickail H, Perez-Gutthann S, McHale M, Grana JM, Marquez P.

Drug Saf. 2006;29(8):657-73. Review.

PMID:
16872240
14.

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
15.

Canadian and US drug approval times and safety considerations.

Rawson NS, Kaitin KI.

Ann Pharmacother. 2003 Oct;37(10):1403-8.

PMID:
14519031
16.

Safety learning from drugs of the same class: room for improvement.

Stefansdottir G, Knol MJ, Arnardottir AH, van der Elst ME, Grobbee DE, Leufkens HG, De Bruin ML.

Clin Pharmacol Ther. 2012 May;91(5):872-80. doi: 10.1038/clpt.2011.319.

PMID:
22453192
17.

Non-clinical Post-Marketing Commitments for newly licenced pharmaceuticals.

Reeve LM.

Regul Toxicol Pharmacol. 2009 Nov;55(2):181-7. doi: 10.1016/j.yrtph.2009.07.001.

PMID:
19589365
18.

The Weber effect and the United States Food and Drug Administration's Adverse Event Reporting System (FAERS): analysis of sixty-two drugs approved from 2006 to 2010.

Hoffman KB, Dimbil M, Erdman CB, Tatonetti NP, Overstreet BM.

Drug Saf. 2014 Apr;37(4):283-94. doi: 10.1007/s40264-014-0150-2. Erratum in: Drug Saf. 2014 May;37(5):381.

19.
20.

Monitoring drug safety in Astrakhan, Russia.

Kirilochev OO, Dorfman IP, Umerova AR.

Int J Risk Saf Med. 2015;27 Suppl 1:S33-4. doi: 10.3233/JRS-150680.

PMID:
26639700

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