Clinical Pharmacogenomics: Premarket Evaluation in Early-Phase Clinical Studies and Recommendations for Labeling
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
January 28, 2013
January 31, 2025
74a84cb7-8271-4fc5-b011-1df725ecf2eb
Related Documents
E3 Structure and Content of Clinical Study Reports - Questions and Answers (R1)
Guidance DocumentJanuary 29, 2013Center for Drug Evaluation and Research
Best Practices for Conducting and Reporting Pharmacoepidemiologic Safety Studies Using Electronic Healthcare Data Sets
Guidance DocumentMay 14, 2013Center for Drug Evaluation and Research
Q11 Development and Manufacture of Drug Substances
Guidance DocumentNovember 20, 2012Center 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