Safety-Related Regulatory Actions for Orphan Drugs in the US and EU: A Cohort Study

Author： Heemstra Harald E.  

Publisher： Adis International

ISSN： 0114-5916

Source： Drug Safety, Vol.33, Iss.2, 2010-02, pp. : 127-137

Disclaimer: Any content in publications that violate the sovereignty, the constitution or regulations of the PRC is not accepted or approved by CNPIEC.

Previous Menu Next

Abstract

Related content

A Cohort Study Exploring Determinants of Safety-Related Regulatory Actions for Biopharmaceuticals

By Ebbers Hans C.  

Drug Safety, Vol. 35, Iss. 5, 2012-05 ,pp. : 417-427

Adis International

Access to resources Recommend Favorite

Assessment of Postmarketing Safety-Related Regulatory Actions in Japan

By Ogami Tetsuro   Imaizumi Takayuki  

Pharmaceutical Medicine, Vol. 26, Iss. 6, 2012-12 ,pp. : 395-403

Adis International

Access to resources Recommend Favorite

Impact of Safety-Related Regulatory Action on Clinical Practice: A Systematic Review

By Piening Sigrid  

Drug Safety, Vol. 35, Iss. 5, 2012-05 ,pp. : 373-385

Adis International

Access to resources Recommend Favorite

EU evaluation of high-cost orphan drugs urged

By  

PharmacoEconomics and Outcomes News, Vol. 1, Iss. 661, 2012-01 ,pp. : 2-2

Adis International

Access to resources Recommend Favorite

A Decade of Safety-Related Regulatory Action in the Netherlands: A Retrospective Analysis of Direct Healthcare Professional Communications from 1999 to 2009

By Mol Peter G.M.   Straus Sabine M.J.M.   Piening Sigrid   de Vries Jonie T.N.   de Graeff Pieter A.   Haaijer-Ruskamp Flora M.  

Drug Safety, Vol. 33, Iss. 6, 2010-06 ,pp. : 463-474

Adis International

Access to resources Recommend Favorite