Issue Date: May 1, 2003
Issued by: Center for Veterinary Medicine
Topic(s): Human Food Safety
Status: Final
CVM GFI #118 Mass Spectrometry for Confirmation of Identity of Animal Drug Residues
CVM develops, evaluates, and applies qualitative mass spectrometric methods for confirming the identity of animal drug residues. Methods developed in support of a New Animal Drug Application (NADA methods) are designed for residues of an approved new animal drug used in the approved manner. Methods may also be developed for unapproved new animal drugs or approved new animal drugs used in an unapproved manner (non-NADA methods). This guidance document describes the basic principles recommended by CVM for developing, evaluating and applying these methods. The purpose of this document is to facilitate and expedite coordination between CVM and its stakeholders so these activities may be carried out in a consistent and timely manner. This final document does not commit CVM to accepting a specific method or data package prior to reviewing the relevant data.
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