E2E Pharmacovigilance Planning Guidance

• By: Staff Editor
• Date: November 27, 2016
• Source: http://www.fda.gov/

E2E Pharmacovigilance Planning Guidance

This Pharmacovigilance planning guidance is intended to aid in planning pharmacovigilance activities, especially in preparation for the early post marketing period of a new drug. The main focus of this Guideline is on a Safety Specification and Pharmacovigilance Plan that might be submitted at the time of licence application.

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