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MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH - PharmaFacts
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MANUAL OF POLICIES AND PROCEDURES CENTER FOR DRUG EVALUATION AND RESEARCH

 

MANUAL OF POLICIES AND PROCEDURES
CENTER FOR DRUG EVALUATION AND RESEARCH MAPP 5240.3 Rev. 2

POLICY AND PROCEDURES

OFFICE OF GENERIC DRUGS
Prioritization of the Review of Original ANDAs, Amendments, and Supplements

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PURPOSE

Table of Contents

PURPOSE ..............................................................................1 BACKGROUND ...................................................................1 POLICY .................................................................................2 RESPONSIBILITIES ..........................................................6 PROCEDURES .....................................................................6 EFFECTIVE DATE..............................................................7 CHANGE CONTROL TABLE............................................7

  • This MAPP describes how the review of abbreviated new drug applications (ANDAs), ANDA amendments, and ANDA supplements will be prioritized for review within the Office of Generic Drugs (OGD) and the Office of Pharmaceutical Quality (OPQ).

  • This MAPP is a revision of MAPP 5240.3, Rev. 1, Prioritization of the Review of Original ANDAs, Amendments, and Supplements (August 1, 2014), which revised MAPP 5240.3, Review Order of Original ANDAs, Amendments, and Supplements (October 18, 2006). This MAPP also supersedes MAPP 5240.1, Requests for Expedited Review of Supplements to Approved ANDAs (November 1, 1995). Information relevant to this MAPP is contained in the Draft Guidance for Industry, ANDA Submissions: Amendments and Easily Correctable Deficiencies Pursuant to GDUFA (July 11, 2014) and the Draft Guidance for Industry, Prior Approval Supplements Pursuant to GDUFA (July

    11, 2014).

    CLICK HERE FOR FULL GUIDANCE