NDA guidance
This article was originally published in The Tan Sheet
Executive Summary
FDA draft guidance published in the Federal Register Dec. 8 and entitled "Applications Covered by Section 505(b)(2)" of Waxman/Hatch provides guidance for submitting NDAs for which one or more of the investigations relied upon by the applicant were not conducted by or for the applicant and for which no right of reference or use has been obtained. The document also provides information on procedures for submitting an application for approval of a change from an approved drug
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