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GUIDANCE DOCUMENT

CVM GFI #118 Mass Spectrometry for Confirmation of Identity of Animal Drug Residues May 2003

Download the Final Guidance Document
Final
Docket Number:
FDA-2001-D-0102
Issued by:
Guidance Issuing Office
Center for Veterinary Medicine

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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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2001-D-0102.

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