Good ANDA Submission Practices Guidance for Industry

Good ANDA Submission Practices Guidance for Industry

FDA issues draft guidance for industry, Good ANDA Submission Practices, and companion MAPP, Good ANDA Assessment Practices Today, the FDA issued the draft guidance for industry “Good ANDA Submission Practices,” which highlights common, recurring deficiencies in abbreviated new drug applications (ANDAs) that may lead to a delay in the approval of an ANDA. The guidance also provides recommendations on ways potential and current applicants can avoid these common deficiencies, which may reduce the number of review cycles necessary to meet ANDA approval requirements. To comment on the draft guidance, please visit the public docket, FDA-2017-D-6854. In addition, the FDA published a companion Manual of Policies and Procedures (MAPP 5241.3), “Good ANDA Assessment Practices,” which outlines ANDA assessment practices for the FDA Office of Generic Drugs (OGD) and Office of Pharmaceutical Quality (OPQ). The MAPP formalizes several recent enhancements to the efficiency of FDA’s ANDA assessment practices, including improvements to operational effectiveness, clarification of staff responsibilities, and the establishment of consistent, clear communication between the FDA and applicants regarding deficiencies that must be corrected for their ANDAs to be approved. As part of the Commissioner’s Drug Competition Action Plan, the FDA is publishing these documents to streamline the ANDA assessment process, provide clarification and assistance to current and potential applicants, and, ultimately, expand access to low-cost, high-quality medicines.