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Home » Balance Needed Between Clarity, Restrictions in EU Plan for Postauthorization Efficacy Studies: Stakeholders
Balance Needed Between Clarity, Restrictions in EU Plan for Postauthorization Efficacy Studies: Stakeholders
March 19, 2013
Allowing competent authorities to require Phase IV efficacy studies before or after product approval could dampen innovation and slow access to new treatments in the EU, industry and other stakeholders say.