Supplements and Other Changes to Approved New Animal Drug Applications

概要

The Food and Drug Administration (FDA) is amending its regulations on supplements and other changes to approved new animal drug applications (NADAs) or abbreviated new animal drug applications (ANADAs) to implement the manufacturing changes provision of the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). The final rule requires manufacturers to assess the effect of a manufacturing change on the identity, strength, quality, purity, and potency of a drug as those factors relate to the safety or effectiveness of the drug. The final rule sets forth requirements for changes requiring submission and approval of a supplement before the distribution of the drug made using the change, changes requiring the submission of a supplement at least 30 days prior to the distribution of the drug, changes requiring the submission of a supplement at the time of distribution of the drug, and changes to be described in an annual report.