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New Drug Application 505(b)(2) Fraud

a New Drug Application (NDA) submitted under section 505(b)(1) of the Federal Food Drug, and Cosmetic Act for a drug for which one or more of the investigations relied on by the applicant for approval of the “application” were not conducted by or for the applicant and for which the applicant has not obtained a right of reference or use from the person by or for whom the investigations were conducted” (21 U.S.C. 355(b)(2)). See New Drug Application (NDA) Fraud in this Glossary.

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