The risks of risk aversion in drug regulation

Author:

Eichler Hans-Georg,Bloechl-Daum Brigitte,Brasseur Daniel,Breckenridge Alasdair,Leufkens Hubert,Raine June,Salmonson Tomas,Schneider Christian K.,Rasi Guido

Publisher

Springer Science and Business Media LLC

Subject

Drug Discovery,Pharmacology,General Medicine

Reference85 articles.

1. European Medicines Agency (EMA). Benefit–risk methodology project. Work package 1 report: description of the current practice of benefit-risk assessment for centralised procedure products in the EU regulatory network. EMA website [online] , (2011).

2. Beckman, R. A., Clark, J. & Chen, C. Integrating predictive biomarkers and classifiers into oncology clinical development programmes. Nature Rev. Drug Discov. 10, 735–748 (2011).

3. Manski, C. Adaptive partial drug approval: a health policy proposal. Economists' Voice 6, 1–5 (2009).

4. Commission of the European Communities. Communication from the commission on the precautionary principle. EC website [online] , (2000).

5. Wiener, J. B. Whose precaution after all? A comment on the comparison and evolution of risk regulatory systems. Duke Journal Comparative International Law 13, 207 (2003).

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