Proposed Criteria for “First Generic” Submissions for Purposes of Abbreviated New Drug Application Review Prioritization Under the Generic Drug User Fee Amendments; Establishment of a Public Docket

摘要

The Food and Drug Administration (FDA or the Agency) is announcing the opening of a public docket and requesting comments on proposed criteria for "first generic" abbreviated new drug application (ANDA) submissions. The purpose is to facilitate FDA's establishment of review prioritization under the Generic Drug User Fee Amendments of 2012 (GDUFA). Establishing clear criteria for this review prioritization category will allow FDA to appropriately prioritize ANDA submissions and track them in a manner consistent with the review prioritization commitments FDA made under GDUFA. Clear criteria for this category will also lead to less industry confusion and more consistent identification of "first generic" submissions.