In the February 6, 2015, Federal Register, FDA issued a proposed rule to implement Title XI of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 ("MMA") governing the approval of 505(b)(2) applications and abbreviated new drug applications ("ANDAs"). According to FDA, it has been implementing the MMA directly from the statute for several years and now seeks to amend its regulations to codify current practice and policy. The proposed rule aims to streamline requirements related to submission of certain patent information, including: Paragraph IV certifications, corrections and changes, timing of submissions, amending or supplementing patent certifications, notification of commercial marketing, and notification of court actions or documented agreements. Comments due May 7, 2015.
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