CVM GFI #279 Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered to be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
June 21, 2024
June 20, 2024
6563f603-dbc6-4d95-942f-0438c0f7d455
Related Documents
CVM GFI #278 Human User Safety in New and Abbreviated New Animal Drug Applications
Guidance DocumentJune 21, 2024Center for Veterinary Medicine
CVM GFI #261 - Eligibility Criteria for Expanded Conditional Approval of New Animal Drugs
Guidance DocumentJuly 14, 2021Center for Veterinary Medicine
CVM GFI #272 Practices to Prevent Unsafe Contamination of Animal Feed from Drug Carryover
Guidance DocumentJanuary 30, 2023Center for Veterinary Medicine
Quick Actions
Transform Regulatory Data into Actionable Intelligence
Join leading pharmaceutical and medical device companies who trust KeyPedia for their regulatory compliance needs.