Assessing User Fees Under the Over-the-Counter Monograph Drug User Fee Program
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
November 1, 2022
November 1, 2022
cd0a751e-3682-43b3-b40d-fb7c5e1da162
Related Documents
Requests for Reconsideration at the Division Level Under GDUFA
Guidance DocumentOctober 16, 2024Center for Drug Evaluation and Research
Competitive Generic Therapies
Guidance DocumentOctober 5, 2022Center for Drug Evaluation and Research
Assessing User Fees Under the Generic Drug User Fee Amendments of 2022
Guidance DocumentJune 9, 2023Center 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