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USFDA Guidance: MAPP: Filing Review of Abbreviated New Drug Applications

The FDA revised section 5200.14 of the Manual of Policies and Procedures (MAPP), "Filing Reviews of Abbreviated New Drug Applications (ANDAs)," on October 2, 2023, to reflect the current ANDA filing review process.

The U.S. Food and Drug Administration (FDA) plays a pivotal role in this process by ensuring the safety and efficacy of medications. One crucial aspect of this oversight is the review of Abbreviated New Drug Applications (ANDAs) and the FDA's updated Manual of Policies and Procedures (MAPP) for the filing review of ANDAs.

Abbreviated New Drug Applications, or ANDAs, are a pathway for pharmaceutical companies to seek FDA approval for generic drugs.

The FDA's MAPP outlines the FDA's internal policies and procedures for reviewing ANDAs, ensuring consistency and efficiency in the evaluation process.

As part of the revised MAPP, an ANDA Filing Checklist has also been added in order to assist Division of Filing Review (DFR) reviewers in assessing the information and data in ANDAs.

The Policy mainly states that

  • DFR Reviewers will use the attached ANDA Filing Checklist (the checklist) to identify the required and recommended content in an ANDA.

  • The DFR Reviewer will not review an applicant’s completed checklist during the filing review. (Some applicants submit a completed checklist with the submission.)

  • The attached checklist follows the Common Technical Document (CTD) format and backbone and specifies the content of each module of the submission.

  • DFR will update the checklist as necessary. The updates may reflect, for example, revised recommendations and/or guidances pertaining to the technical reviews that are conducted for an ANDA.

  • At the conclusion of the filing review, the DFR Reviewer will determine whether to receive the ANDA, issue an Information Request (IR) to the applicant providing an opportunity to remedy identified deficiencies, or refuse-to-receive the ANDA.

To know more exclusively about the "Filing Review of Abbreviated New Drug Applications" click this LINK.


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