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Zdrowie i gospodarka · 23.10.2009

New Animal Drug Applications

The Food and Drug Administration (FDA) is proposing to amend the regulations regarding new animal drug applications (NADAs). Specifically, this proposed rule is being issued to provide that NADAs shall be submitted in the form and containing the information described, 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 amendment will allow the agency to appropriately review safety and effectiveness data submitted to support the approval of new animal drug products. This proposed rule is a companion document to the direct final rule published elsewhere in this issue of the Federal Register.

Source: Federal Register — Food and Drug AdministrationOpen original release →