Writing Resources
Organizations
- American Medical Writers Association
- British National Formulary
- Drug Information Association
- EMEA Index of Documents (including ICH guidelines)
- European Agency for the Evaluation of Medicinal Products (EMEA)
- European Association of Science Editors (EASE)
- European Medical Writers Association
- Food and Drug Administration (US)
- Food and Drug Administration (US) - Center for Drug Evaluation and Research
- Medicines and Healthcare Products Regulatory Agency - Medicines Control Agency
- World Health Organization
Guidelines
- FDA Guidance Documents
- FDA Guidance: Abbreviated Reports and Synopses [FDA CDER website]
- ICH Official Site
- ICH Clinical Overview and Clinical Summary (Module 2) and Clinical Study Reports (Module 5) [ICH Website]
- ICH E3 Structure and Content of Clinical Study Reports [ICH Website]
- ICH E9 Statistical Principles for Clinical Trials [ICH Website]
- ICH - GCP Guidelines for Clinical Trials