Revised MAPP: Good ANDA Assessment Practices

https://www.fda.gov/media/110017/download?utm_medium=email&utm_source=govdelivery Today, FDA revised Manual of Policies and Procedures (MAPP 5241.3), “Good ANDA Assessment Practices,” which outlines abbreviated new drug application (ANDA) assessment practices for the FDA Office of Generic Drugs (OGD) and Office of Pharmaceutical Quality (OPQ) to increase their operational efficiency and effectiveness, with a goal of decreasing the number of review cycles needed to approve ANDAs that meet the requirements for approval. Under the Generic Drug User Fee Amendments of 2012 (GDUFA I), FDA implemented a restructuring of the ANDA assessment program. As part of this restructuring, FDA adopted performance goals for the review of ANDAs; overhauled the generic drug program’s business processes; developed and implemented an integrated ANDA review information platform; reorganized OGD; established OPQ to, among other things, integrate the ANDA quality assessment; and hired and trained more than 1,000 employees. As a direct result of this restructuring, FDA’s efficiency and output from ANDA review improved, including issuance of complete response letters as well as increased ANDA approvals. Most recently, the generic drug user fee program was reauthorized as part of the Continuing Appropriations and Ukraine Supplemental Appropriations Act, 2023. As described in the GDUFA III commitment letter applicable to this latest reauthorization, FDA has agreed to performance goals and program enhancements regarding aspects of the generic drug assessment program that build on previous authorizations of GDUFA. New enhancements to the program are designed to maximize the efficiency and utility of each assessment cycle, with the intent of continuing to reduce the number of assessment cycles for ANDAs and facilitating timely access to generic medicines. FDA previously published this MAPP concurrently with the guidance for industry Good Abbreviated New Drug Application Submission Practices. This guidance highlights common, recurring deficiencies that may delay approval of an ANDA and makes recommendations to applicants on how to avoid these deficiencies. The guidance and this MAPP build upon the success of the generic drug user fee program to help reduce the number of assessment cycles for an ANDA to attain approval. FDA published these documents as part of the Drug Competition Action Plan, which aims to provide clarification and assistance to current and potential applicants, and, ultimately, expand access to low-cost, high-quality medicines.