Investigational New Drug Applications Prepared and Submitted by Sponsor-Investigators
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
May 15, 2015
May 14, 2020
9c10b828-60b1-4f2f-acda-7011cf2ad95d
Related Documents
Risk Management Plans to Mitigate the Potential for Drug Shortages
Guidance DocumentMay 19, 2022Center for Drug Evaluation and Research
Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials
Guidance DocumentApril 9, 2018Center for Drug Evaluation and Research
Rheumatoid Arthritis: Developing Drug Products for Treatment
Guidance DocumentMay 31, 2013Center 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.
Stay ahead of FDA enforcement
New KeyPedia insights, webinars, and regulatory analysis — straight to your inbox. Unsubscribe anytime.