Ordinarily, for Category I supplemental NADA's, FDA does not require a reevaluation of any of the safety or effectiveness data in the parent application. For Category II supplemental NADA's, FDA may ordinarily require drug sponsors to submit new data. Therefore, the Center may be required to reevaluate certain safety or effectiveness data in the original application. The draft guidance lists the types of supplemental NADA's that fall into each of the categories, and it provides an overview of issues that drug sponsors should consider with respect to safety and effectiveness data and data supporting the environmental and manufacturing controls technical sections when seeking the approval of Category II supplemental NADA's. The draft guidance is organized by type of Category II supplement.
Comments provide additional information to assist the sponsor.
In this way, the draft guidance specifies data requirements that will avoid duplication of previously submitted data. It also refers drug sponsors to related guidance documents that will aid them in the preparation of supplemental NADA's. This draft guidance does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirement of the applicable statute, regulations, or both. When CVM determines that a product represents an important advance in animal health, it may expedite the review of original and supplemental applications.