Comment from Generic Animal Drug Alliance
AnonymousSupportTrade association
Summary: The Generic Animal Drug Alliance (GADA) supports the draft guidance but requests clarifications regarding labeling requirements for generic products and the specific stability data needed for products with short shelf lives. They also advocate for a more risk-based approach to stability testing to reduce the complexity and cost of testing across multiple feed types and inclusion levels.
The Generic Animal Drug Alliance (GADA) appreciates the opportunity to provide comments on Draft Guidance for Industry #91: Stability Testing for Medicated Premixes (Revision 1) VICH GL8(R). Please see our comments in the attached document.