The FDA will amend the new animal drug application (NADA) regulations to require NADAs be submitted in triplicate and contain all information in the NADA submission as described and appropriate for the particular submission. The direct final rule will allow the FDA to review safety and effectiveness data submitted to support the approval of new animal drug products. In addition, the direct final rule will make the new human and new animal drug regulations more consistent in regards to application procedures. The direct final rule will be effective on March 8, 2010.
SOURCE: FDA Direct Final Rule
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