This List of Guidances for Statistics in Regulatory Affairs presents a source of references for statistical guidance documents and related articles that are relevant to regulatory affairs for those statisticians that work on clinical studies.
Abbreviations EMA = European Medicines Agency EU-HTA = European Commission Health Technology Assessment FDA = U.S. Food and Drug Administration ICH = International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use IQWiG = Institute for Quality and Efficiency in Health Care UK-NICE = National Institute for Health and Care Excellence
Drugs