In an effort to improve consistency and reduce confusion in new animal drug applications (NADA), the FDA has issued Guidance for Industry 191. This guidance is intended to assist sponsors who wish to apply for approval of changes to approved new animal drugs that require FDA to reevaluate safety and/or effectiveness data. The guidance explains how the Office of New Animal Drug Evaluation (ONADE) categorizes possible changes to approved new animal drugs that require reevaluation of safety and/or effectiveness data and explains which administrative vehicle — a new original new animal drug application (new NADA) or a Category II supplemental application to the original new animal drug application (Category II supplemental NADA) — a sponsor should use when applying for approval of these changes. The goal of this guidance is to create greater consistency in how such applications are handled by sponsors and by ONADE.

The guidance text and Appendix III are updated to clarify the Center for Veterinary Medicine’s (CVM’s) current thinking on the appropriate terminology for classes of major food-producing animals. For example, the CVM Update of February 21, 2012, clarified the term “non-lactating dairy cattle” to avoid potential drug residue issues for dry dairy cows. CVM no longer uses the term “non-lactating dairy cattle” on the labeling for new animal drugs. Also, the use of the term “species” is minimized and generally replaced with the term “target animal,” which reflects CVM’s preferred term to use describing the animals for which a drug is approved. Similarly, the term “claim” has been replaced with the more accurate term “indication.”

FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.

In the past, applications for changes to approved new animal drugs may have been handled inconsistently by sponsors and the Agency. For example, in some instances, a sponsor may have filed an application for a specific change as a new NADA; in other instances an application for a similar change was filed as a supplemental NADA. Inconsistency in handling such applications has been confusing for sponsors and for ONADE, particularly when reviewing and referencing the history of specific NADAs. This guidance is intended to improve consistency in the way applications for changes are handled. For these reasons, we believe that consistent handling of these types of applications also will help maintain clarity in the administrative record, which is an important part of protecting the public health.

View the full guidance document from FDA.