Communicating Certain Deficiencies Identified During Filing Review of ANDAs

Communicating Certain Deficiencies Identified During Filing Review of ANDAs

On September 28, 2017, the FDA published a new section of the Manual of Policies and Procedures (MAPP 5220.3), “Communicating Certain Deficiencies Identified During Filing Review of ANDAs.” This MAPP outlines the Office of Generic Drugs’ (OGD) policies and procedures for communicating with applicants regarding abbreviated new drug applications (ANDAs) that contain minor technical deficiencies and/or deficiencies that may be resolved with additional clarification from the applicant. This MAPP applies to the Division of Filing Review (DFR) Reviewers and Project Managers (DFR PMs) in OGD. The publication of this MAPP fulfills the commitment made by FDA as part of the Generic Drug User Fee Amendments Reauthorization (GDUFA II) to issue a MAPP on the communication of minor technical deficiencies and deficiencies potentially resolved with information in the ANDA at original submission. This MAPP focuses on how DFR reviewers and DFR PMs issue Information Requests (IRs) for minor deficiencies and notify applicants of major deficiencies that may be resolved with information in the original ANDA submission. Direct link to the MAPP: https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/ CDER/ManualofPoliciesProcedures/UCM578093.pdf