priority review

(1)The term “priority review”, with respect to a human drug application as defined in, means review and action by the Secretary on such application not later than 6 months after receipt by the Secretary of such application, as described in the Manual of Policies and Procedures of the Food and Drug Administration and goals identified in the letters described in section 101(c) of the Food and Drug Administration Amendments Act of 2007.


21 USC § 360n(a)(1)

Scoping language

In this section
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