356h 表格与 ANDA 提交材料中常见的差异-Ihezie-Nguyen.pdf

1、Common Discrepancies Observed on the Form 356h with theANDA SubmissionOnyeka Ihezie,PharmDRegulatory Business Process ManagerDivision of Regulatory and BusinessProcess Management I(DRBPMI)OPRO|OPQ|CDERGeneric Drugs Forum 2025 April 9,2025Thaoly Nguyen,PharmDRegulatory Business Process ManagerDivisio

2、n of Regulatory and BusinessProcess Management III(DRBPMIII)OPRO|OPQ|CDERfda.gov/cdersbiafda.gov/cdersbia2Learning Objectives Describe the purpose of Form 356h Why is it important?Formal cover document for submissions Ensures required information is provided FDA Guidance for Industry on 356h Common

3、Discrepancies Observed Impact on ANDA Submissions Agency Recommendationfda.gov/cdersbiafda.gov/cdersbia3Introduction Purpose of FDA Form 356h in ANDAs The role of FDA in reviewing the form The importance of accurate and complete submissionsfda.gov/cdersbiafda.gov/cdersbia4Key Sections of Form 356h A

4、pplicant Information Product Information Establishment Details Clinical&Non-clinical datafda.gov/cdersbiafda.gov/cdersbia5FDA Guidance for Industry on Form 356hfda.gov/cdersbiafda.gov/cdersbia6FDA Guidance for Industry on Form 356h Consistency in application data Common pitfalls and errors identifie

5、d by FDA How to properly complete each sectionfda.gov/cdersbiafda.gov/cdersbia7Top 10 Most Common Discrepancies Observed fda.gov/cdersbiafda.gov/cdersbia8#10 Full version of form 356h with all establishments included in quality-related submissions,but a shortened version is used for non-Quality rela

6、ted submissions.Impact:Facility information request Recommendation:Consistently submit the full form 356hfda.gov/cdersbiafda.gov/cdersbia9#9 Form 356h is missing in a grouped supplement for non-lead applications Impact:Information request,Delayed start to evaluation Recommendation:Confirm a separate