Since the ICH E3 guidance was made final, experiences implementing the guidance in the ICH regions have given rise to requests for clarification. This question and answer (Q&A) document is intended to facilitate implementing the ICH E3 guidance by clarifying key issues.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.