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
Medical Devices
Health Technology Assessment (HTA)
See also Guidances for statistics in regulatory affairs Clinical trials Medical statistics Epidemiological method Epidemiology Medicine
References
External links ICH Efficacy Guidelines European Medicines Agency's (EMA) scientific guidelines on biostatistics Archived 2016-06-21 at the Wayback Machine FDA Regulatory Information - Guidances