USFDA issues guidance for Animal Drug Applications – (A)NADAs.

USFDA has issued a new guidance for primary batches to be included in the CMC section in Animal Drug Applications. The guidance is applicable for New Animal Drug Applications (NADAs), Abbreviated New Animal Drug Applications (ANADAs) and associated applications like INADs, JINADs, CNADAs. A minimum of 3 cGMP primary batches shall be manufactured of the same formulation and packed in same container closure system. The primary batches shall be manufactured with two or batches of active ingredient from same source. The batch size for the primary batches should be no less than 10% of the intended commercial batches. It is recommended to manufacture the primary batches at the same manufacturing site as intended for commercial batches. At least 6 months stability data need to be included in the CMC section of the drug product application, however submission of application may be made with 3 months data with additional data submitted through amendment process while the application is in the review queue. Bracketing approach is acceptable when the drug product has multiple strengths, different fill volumes, container sizes etc. Applicants may request a meeting with DMT to discuss the bracketing approach. Any addition of new sources for actives shall be made through supplements. For addition of new source of actives, comparability of CQAs of drug substance, comparative dissolution data of the drug product etc need to be provided. The drug substance batches shall also be cGMP batches. Any animal safety or effectiveness studies, bioequivalence studies, human food safety studies etc for the drug product shall be performed with primary batches.

CVM GFI #285 – Manufacture of Batches in Support of Original NADAs, ANADAs, and CNADAs