As an applicant, you are responsible for assessing, prior to distribution of a product, the effect of any postapproval CMC changes on the identity, strength, quality, purity, and potency of the product as these factors relate to the safety or efficacy of the product (section 506A(b) of the Federal Food, Drug, and Cosmetic Act). Such an assessment often includes demonstration that the pre- and postchange products (i.e., products manufactured prior to and subsequent to a change) are equivalent.

This guidance provides recommendations to applicants on preparing and using comparability protocols for postapproval changes in chemistry, manufacturing, and controls (CMC). The guidance applies to comparability protocols that would be submitted in new animal drug applications (NADAs), abbreviated new animal drug applications (ANADAs), or supplements to these applications. Well-characterized synthetic peptides submitted in these applications are included within the scope of this guidance. This guidance also applies to comparability protocols submitted in investigational new animal drug (INAD), generic investigational new animal drug (JINAD) and veterinary master file (VMF) submissions that are referenced in applications.

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