List of Guidances for Statistics in Regulatory Affairs

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
• FDA Regulatory Information - Guidances