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