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Zdrowie i gospodarka · 01/04/2005

FDA Releases Guidance on E2E Pharmacovigilance Planning

The FDA has made available a guidance document titled 'E2E Pharmacovigilance Planning' developed under the ICH framework, outlining a method for assessing drug risks and proposing a pharmacovigilance plan for new pharmaceuticals.

Source: Federal Register — Food and Drug AdministrationOpen original release →