ANDA Submissions — Content and Format of Abbreviated New Drug Applications: Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
June 20, 2019
April 21, 2020
9e96159f-7071-4167-b6c2-79004f8ffc79
Related Documents
Referencing Approved Drug Products in ANDA Submissions Guidance for Industry
Guidance DocumentOctober 27, 2020Center for Drug Evaluation and Research
E8(R1) General Considerations for Clinical Studies
Guidance DocumentApril 8, 2022Center for Drug Evaluation and Research
Format and Content of a REMS Document Guidance for Industry
Guidance DocumentJanuary 4, 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