$MNKD A 505(b)(2) application is an NDA that contains full reports of investigations of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant, and for which the applicant has not obtained a right of reference or use, including, for example, the Agency’s finding of safety and/or effectiveness for a listed drug or published literature. NDAs requiring full reports of investigations of safety and effectiveness that were conducted by or for the applicant, or for which the applicant has a right of reference or use, known as “stand-alone” NDAs, are submitted under section 505(b)(1) of the FD&C Act.
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