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Abbreviated New Drug Applications and 505 (b) (2) Applications (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library

Abbreviated New Drug Applications and 505(b)(2) Applications (US Food and Drug Administration Regulation) (FDA) (2018 Edition) The Law Library presents the complete text of the Abbreviated New Drug Applications and 505(b)(2) Applications (US Food and Drug Administration Regulation) (FDA) (2018 Edition). Updated as of May 29, 2018 The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA), which amended provisions of the Federal Food, Drug, and Cosmetic Act (the FD& C Act) that govern the approval of 505(b)(2) applications and abbreviated new drug applications (ANDAs). This final rule implements portions of Title XI of the MMA that pertain to provision of notice to each patent owner and the new drug application (NDA) holder of certain patent certifications made by applicants submitting 505(b)(2) applications or ANDAs; the availability of 30-month stays of approval on 505(b)(2) applications and ANDAs that are otherwise ready to be approved; submission of amendments and supplements to 505(b)(2) applications and ANDAs; and the types of bioavailability and bioequivalence data that can be used to support these applications. This final rule also amends certain regulations regarding 505(b)(2) applications and ANDAs to facilitate compliance with and efficient enforcement of the FD& C Act. This book contains: - The complete text of the Abbreviated New Drug Applications and 505(b)(2) Applications (US Food and Drug Administration Regulation) (FDA) (2018 Edition) - A table of contents with the page number of each section