Assessing the Irritation and Sensitization Potential of Transdermal and Topical Delivery Systems for ANDAs: Draft Guidance for Industry
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
April 13, 2023
April 14, 2023
1472ed4f-fea1-4017-b0d7-d7fcd5e86e6d
Related Documents
Quality Considerations for Topical Ophthalmic Drug Products
Guidance DocumentDecember 27, 2023Center for Drug Evaluation and Research
Topical Dermatologic Corticosteroids: In Vivo Bioequivalence
Guidance DocumentOctober 24, 2023Center for Drug Evaluation and Research
Assessing Adhesion With Transdermal and Topical Delivery Systems for ANDAs Draft Guidance for Industry
Guidance DocumentApril 12, 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