Sistema de Información Esencial en Terapéutica y Salud

@SIETES7

Última actualización: 18/9/2019
SIETES contiene 92806 citas

 
 
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1.Enlace a cita original Cita con resumen
Beall RF, Hwang TJ, Kesselheim AS. Major events in the life course of new drugs, 2000–2016. N Engl J Med 2019;380:14 de marzo. [Ref.ID 103056]
2.Enlace a cita original Cita con resumen
Puthumana J, Wallach JD, Ross JS. Clinical trial evidence supporting FDA approval of drugs granted breakthrough therapy designation. JAMA 2018;319:17 de julio. [Ref.ID 102793]
3. Cita con resumen
Swetlitz I. Gottlieb pushes back against criticism of ‘breakthrough’ designation. STAT Daily Recap 2018:5. [Ref.ID 102595]
4.Enlace a cita original Cita con resumen
Webster P. Pimavanserin evaluated by the FDA. Lancet 2018;391:5 de mayo. [Ref.ID 102594]
5. Cita con resumen
Hamel MB. Speed, safety, and industry funding — From PDUFA I to PDUFA VI. N Engl J Med 2017;377:2278-86. [Ref.ID 102166]
6. Cita con resumen
Santoro A, Genov G, Spooner A, Raine J, Arlett P. Promoting and protecting public health: how the European Union pharmacovigilance system works. Drug Saf 2017;40:855-69. [Ref.ID 102075]
7. Cita con resumen
Woloshin S, Schwartz LM, White B, Moore TJ. The fate of FDA postapproval studies. N Engl J Med 2017;377:1114-7. [Ref.ID 102072]
8. Cita con resumen
Rosenberg HG, Shnier A. Regulatory data are hidden in plain sight. BMJ 2017;358:j3437. [Ref.ID 101980]
9. Cita con resumen
Downing NS, Shah ND, Aminawung JA, Pease AM, Zeitoun JD, Krumholz HM, Ross JS. Postmarket safety events among novel therapeutics approved by the US Food and Drug Administration between 2001 and 2010. JAMA 2017;317:1854-63. [Ref.ID 101567]
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11.Tiene citas relacionadas Cita con resumen
Davis C, Lexchin J, Jefferson T, Gotzsche P, McKee M. "Adaptive pathways” to drug authorisation: adapting to industry?. BMJ 2016;354:i4437. [Ref.ID 100602]
12. Cita con resumen
Hawkes N. Specialists attack drug agency’s fast track approval scheme. BMJ 2016;353:i3060. [Ref.ID 100382]
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