Guidance for Industry: Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance ([numsign]118) entitled "Guidance For Industry: Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues." This guidance describes the basic principles the agency recommends for development, evaluation, or application of qualitative mass spectrometric methods for confirming the identity of new animal drug residues. This guidance document is intended for technical professionals familiar with mass spectrometry. A glossary at the end of the guidance defines key terms used throughout the document.