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FDA Corrects Rule on ANDAs, 505(b)(2)s

03/13/2015

Federal Register Correction: FDA is making several corrections to a 2/6/15 proposed rule, pages 6801-6896, that proposed regulations to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003, which amended provisions of the FD&C Act that govern the approval of 505(b)(2) applications and abbreviated new drug applications. To view this correction, click here.

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