US 505(b)(2) Regulatory Pathway and Strategies
US 505(b)(2) Regulatory Pathway and Strategies
US 505(b)(2) Regulatory Pathway and Strategies
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Defining the <strong>505</strong>(b)(2) ApplicationA <strong>505</strong>(b)(2) application is one for which one or more of the investigationsrelied upon by the applicant for approval "were not conducted by or forthe applicant <strong>and</strong> for which the applicant has not obtained a right ofreference or use from the person by or for whom the investigationswere conducted" (21 U.S.C. 355(b)(2)).