Zdrowie i gospodarka · 28.04.2004
Draft Guidance for Industry: Validation of Analytical Procedures for Type C Medicated Feeds
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry ( 135) entitled "Validation of Analytical Procedures for Type C Medicated Feeds." This draft guidance represents the agency's current thinking on the characteristics that should be considered during the validation of non- microbiological analytical procedures for the analysis of drugs in Type C medicated feeds included as part of original and supplemental new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) for Type A medicated articles submitted to the FDA. This draft guidance is the first in a series of three guidances that will discuss assay methods for Type C medicated feeds.