New rules affecting new drug application holders and follow-on applicants will take effect on December 5, 2016.

On October 6, 2016, the US Food & Drug Administration (FDA or the Agency) published a 79-page final rule (the Final Rule) in the Federal Register, revising its regulations governing the requirements for submission and approval of Abbreviated New Drug Applications (ANDAs) submitted under Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FDCA) and New Drug Applications (NDA) submitted under Section 505(b)(2) of the FDCA (505(b)(2) applications).1 The Final Rule finalizes a comprehensive proposed rule that was published on February 6, 2015 (the Proposed Rule),2 and in response to which FDA received 13 comment letters. According to FDA, the Final Rule implements portions of Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) by formalizing many Agency policies developed over its 13 years of implementing the statute, while also revising and clarifying FDA’s existing regulations on ANDAs and 505(b)(2) applications. Notably, the Final Rule does not address issues related to the circumstances under which an ANDA applicant may be deemed to have forfeited 180-day exclusivity under Section 505(j)(5)(D) of the FDCA. FDA instead states that it will continue to implement those provisions of the MMA directly from the statute, and may issue a separate rule at a later date.