International Conference on Harmonisation; guidance on E2E Pharmacovigilance Planning; availability. Notice
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Updated: Aug 18, 2026

High Content Screening Analysis to Evaluate the Toxicological Effects of Harmful and Potentially Harmful Constituents (HPHC)
Published on: May 10, 2016
Abstract:
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "E2E Pharmacovigilance Planning." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes a method for summarizing the important potential and identified risks of a drug. It proposes a structure for a pharmacovigilance plan and sets out principles of good practice for the design and conduct of observational studies. The guidance is intended to aid in planning pharmacovigilance activities, especially in preparation for the early postmarketing period of a new drug.
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