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FDA Issue Final Rule on Abbreviated New Drug Applications

November 7, 2016

The US Food and Drug Administration (FDA) issued a final rule focused on abbreviated new drug applications on October 6, 2016.

The final rule aims to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA). This final rule specifies the implementation of the 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.

This final rule is effective starting December 5, 2016.