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Home » FDA Seeks Input on ICH Draft on Design, Use of RWD in Safety Assessments
FDA Seeks Input on ICH Draft on Design, Use of RWD in Safety Assessments
The FDA is proposing to adopt a new guideline from the International Council for Harmonisation (ICH) on the use of real-world data (RWD) in pharmacoepidemiological studies of drug, vaccine and other biologic products, including recommendations for high-level best practices for these studies.