Reporting Associated with New Animal Drug Applications and Veterinary Master Files

Any person may file a new animal drug application (NADA) seeking FDA approval to legally market a new animal drug. The application must include safety and effectiveness data, proposed labeling, product manufacturing information, and where necessary, complete information on food safety (including microbial food safety) and any methods used to determine residues of drug in edible tissue from food producing animals. FDA Guidance #152 outlines a risk assessment approach for evaluating the microbial food safety of antimicrobial new animal drugs. We request that applicants utilize Form FDA 356V, as appropriate, to ensure efficient and accurate processing of information to support new animal drug approval. Respondents may choose to use veterinary master files to provide and organize confidential detailed information to the Agency. Veterinary master files can be used as repositories for information that can be referenced in multiple submissions to the Agency, thus minimizing paperwork burden.

The latest form for Reporting Associated with New Animal Drug Applications and Veterinary Master Files expires 2022-07-31 and can be found here.