D1S06-Phung-v1.2-FINAL.pdf

1、Proactive Strategies to Avoid Major Filing Deficiencies&Other Stumbling BlocksTruong-Vinh(Vinh)Phung,PharmDCommander,US Public Health ServiceRegulatory OfficerDivision of Filing Review(DFR),Office of Generic Drugs(OGD)CDER|US FDAGeneric Drugs Forum April 22,20262Learning ObjectivesUnderstand OGDs Mi

2、ssion and DFRs PurposeLeverage FDA resourcesRecognize filing major deficienciesDescribe stumbling blocks Provide justifications to deviate from requirements and/or recommendationswww.fda.gov3MissionEnsures high-quality,affordable generic drugs are available to the American publicFiling review determ

3、ines whether an ANDA is substantially complete to permit substantive reviewDivision of Filing Reviews objective:File substantially complete ANDAs(ideally,without issuing an Information Request)Maintain and apply uniform review standardswww.fda.gov4FDA ResourcesANDA Submissions Refuse-to-Receive Stan

4、dards(December 2016)ANDA Submissions Refuse-to-Receive Standards:Questions and Answers(October 2017)ANDA Submissions Refuse to Receive for Lack of Justification of Impurity Limits(August 2016)ANDA Submissions Content and Format of ANDAs(June 2019)Filing Review of ANDAs MAPP 5200.14(includes filing c

5、hecklist)www.fda.gov5FDA ResourcesANDAs:Stability Testing of Drug Substances and Products,Questions and Answers(May 2014)Guidance for Industry ANDAs:Stability Testing of Drug Substances and Products(June 2013)Content and Format of Composition Statement and Corresponding Statement of Ingredients in L

6、abeling in NDAs and ANDAs(April 2024)Communicating Certain Deficiencies Identified during Filing Review of ANDAs MAPP 5220.3Product-Specific Guidances(PSG)www.fda.gov6Key Major A deficiency that would result in a refuse-to-receive(RTR)Stumbling Blocks Impacts the ability to file an ANDA Information