Federal Register Direct final rule/proposed rule: FDA is amending the regulations for new animal drug applications (NADAs) so that NADAs shall be submitted in the described form, as appropriate for the particular submission. Currently, the regulation requires that all NADAs contain the same informational sections and does not explicitly provide the appropriate flexibility needed to address the development of all types of new animal drug products. This will allow the agency to appropriately review safety and effectiveness data submitted to support the approval of new animal drug products. To view this direct final rule, click here.