356h 表格與 ANDA 提交材料中常見的差異-Ihezie-Nguyen.pdf

《356h 表格與 ANDA 提交材料中常見的差異-Ihezie-Nguyen.pdf》由會員分享，可在線閱讀，更多相關《356h 表格與 ANDA 提交材料中常見的差異-Ihezie-Nguyen.pdf（26頁珍藏版）》請在三個皮匠報告上搜索。

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

7、 form 356h is included for each ANDA listed in group.fda.gov/cdersbiafda.gov/cdersbia10#8 Email address listed for new responsible official,or US agent is not secure Impact:Delay in receiving correspondence from Agency Recommendation:Advise every new administrative contact to secure email ASAP-Secur

8、eEmailfda.hhs.govfda.gov/cdersbiafda.gov/cdersbia11#7In premarket applications,introducing a new facility to the application but omitting the response to Is the Establishment new to the application?Impact:Prolonged evaluation,Goal Date ExtensionRecommendation:When introducing a new facility that inv

9、olves commercial manufacturing or testing,include proposed change on 356h and cover letter.On 356h,check Yes to Is the Establishment new to the application?;check No if facility was already introduced in a prior review cycle.Facilities should be ready for inspection and marked Pending until applicat

10、ion is fully approved fda.gov/cdersbiafda.gov/cdersbia12Example:Introduction of a Facility in a Pre-market applicationNew facility introduction with current submissionFacility previously introduced in prior assessment cyclefda.gov/cdersbiafda.gov/cdersbia13#6In post-marketing applications,multiple f

11、acilities are proposed among different supplements and submitted concurrently but response to question“Is this establishment involved in the change described in this supplement?”is omitted.Impact:Prolonged evaluationRecommendation:Check Yes to Is the Establishment new to the application?with every n

12、ew facility proposal.Check Yes if applicable to supplement submission and“No”for all other proposed facilities submitted concurrently in a different supplementFacilities should be ready for inspection and marked Pending until supplemental application is approvedfda.gov/cdersbiafda.gov/cdersbia14Intr

13、oduction of a Facility in a Post-market ANDANew facility proposed in a supplemental ANDAFor all other proposed facilities submitted concurrently in a different supplementfda.gov/cdersbiafda.gov/cdersbia15#5 Facilities on form 356h are not reflected in relevant sections of module 3 or vice versa.Impa

14、ct:Facility information request Recommendation:Update all relevant sections of module 3 to reflect form 356hfda.gov/cdersbiafda.gov/cdersbia16#4Facility is marked as“withdrawn”on 356h but there is no reference to the facility withdrawal request on the cover pageImpact:Facility is not withdrawn,CDER

15、collections information requestRecommendation:Include facility withdrawal request on both 356h and cover page In post-market,submit as a standalone CBE-0 or submit with a quality-related supplement fda.gov/cdersbiafda.gov/cdersbia17#3 Previously approved facilities still checked Pending;Withdrawn fa

16、cilities still checked Withdrawn Impact:Prolonged Evaluation Recommendation:Upon receipt of approval action,update facility status to Active;Remove withdrawn facility from formfda.gov/cdersbiafda.gov/cdersbia18#2 FEI number lists the DUNS and vice versa;FEI number doesnt reflect what Agency has.Impa

17、ct:Facility information request Recommendation:Confirm accuracy on FDA data dashboardfda.gov/cdersbiafda.gov/cdersbia19#1 Not all API facilities are listed in the application(356h or Module 3.2)Impact:Facility information request,Goal date extension Recommendation:Applicant should contact DMF holder

18、 to identify and include all API facilities which are used to support commercial manufacturing fda.gov/cdersbiafda.gov/cdersbia20Impact of Errors on ANDA Approval Potential Refuse-to-Receive(RTR)designation Delayed review timelines Additional FDA queries and Information requests(IRs)fda.gov/cdersbia

19、fda.gov/cdersbia21Best Practices for Avoiding Discrepancies Use FDAs most recent 356h guidance,electronic submission tools(eCTD validation),and the FDA data dashboard for firm resources Internally audit by cross-checking details across all submission documents Update the 356h to reflect each facilit

20、ys status prior to a submission Have a question?Contact the applications RBPM or submit a controlled correspondence.fda.gov/cdersbiafda.gov/cdersbia22Key Takeaways Form 356h is critical and must be accurate Accuracy and consistency of Form 356h ensures a smoother ANDA approval process Discrepancies

21、lead to more work for the Agency and for the applicant Discrepancies delay the review timeline fda.gov/cdersbiafda.gov/cdersbia23Questions?fda.gov/cdersbiafda.gov/cdersbia24ResourcesIdentification of Manufacturing Establishments in Applications Submitted to CBER and CDER Questions and Answers Guidan

22、ce for IndustryFDA Form 356h:Application to Market a New or Abbreviated New Drug or Biologic for Human UseGuidance for Industry:Good ANDA Submission PracticesGuidance for Industry:ANDA Submissions Refuse-to-Receive StandardsIdentification of Manufacturing Establishments in Applications Submitted to CBER and CDER:Questions and AnswersCommon Entry Submission ErrorsFDA Data Dashboardfda.gov/cdersbiafda.gov/cdersbia25Closing ThoughtEnsure accuracy on your Form 356h.Review,validate,and follow FDA guidance.A thorough submission today leads to a faster approval tomorrow!