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In mid-March, FDA released Manual of Policies and Procedures (MAPP) 5240.2 on “Prioritization of the Review of Original ANDAs, Amendments, and Supplements.” The MAPP revision replaces an August 2014 version. The 2016 revision includes instructions for the prioritization of sole-source drug products, reflects the reorganization of CDER’s Office of Pharmaceutical Quality, and revises certain forfeiture timeframes consistent with the 2012 FDA Safety and Innovation Act (FDASIA). The MAPP states that submissions for drug products “for which there is only one approved drug product listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) and for which there are no blocking patents or exclusivities may receive expedited review.”
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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
