Integrated Summaries of Effectiveness and Safety: Location Within the Common Technical Document
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
April 21, 2009
April 24, 2020
d5fec113-5b34-45f5-bbbd-3dfd74cb580b
Related Documents
Drug-Induced Liver Injury: Premarketing Clinical Evaluation
Guidance DocumentJuly 29, 2009Center for Drug Evaluation and Research
Electronic Source Data in Clinical Investigations: Guidance for Industry
Guidance DocumentSeptember 18, 2013Center for Drug Evaluation and Research
Q10 Pharmaceutical Quality System
Guidance DocumentApril 8, 2009Center for Drug Evaluation and Research
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust GKS for their regulatory compliance needs.
Try KeyPedia Today
Explore our real use cases and discover our features in depth.
Subscribe to our newsletter
Get the latest updates and insights delivered to your inbox