ANDA 前会议：流程和最佳实践-Sarago.pdf

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1、Pre-ANDA Meetings:Process and Best PracticesCaliope Sarago,MHSALead Regulatory Health Project ManagerOffice of Research and Standards/Office of Generic DrugsCDER|US FDAGeneric Drug Forum 2025 April 9,2025fda.gov/cdersbia2Learning Objectives Describe the purpose and scope of pre-ANDA product developm

2、ent and pre-submission meetings Identify the best meeting pathway for your generic drug development program Discuss helpful tips for creating a successful meeting packagefda.gov/cdersbia3Pre-ANDA Scientific MeetingsProduct Development(PDEV)MeetingsPre-Submission(PSUB)MeetingsFacilitate communication

3、s between FDA and prospective applicants related to complex products and/or complicated drug development questionsfda.gov/cdersbia4Pre-ANDA Scientific MeetingsFDA-EMA Parallel Scientific Advice(PSA)ProgramModel-Integrated Evidence(MIE)Industry Meeting PilotAdditional Pre-ANDA Scientific Meetings ava

4、ilable not covered under GDUFA III that may be more suitable for your program needs.Refer to FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products WebpageExpanding Generic Drug Access Through International Engagements Webinar Model-Integrated Evidence(MIE)Industry Meet

5、ing Pilot Between FDA and Generic Drug Applicants WebpageA Deep Dive:FDAs Model-Integrated Evidence(MIE)Industry Meeting Pilot Program for Generic Drugs Webinar fda.gov/cdersbiaControlled correspondence(CC)Single or small group of closely related questions Single discipline Outside scope of PDEV Res

6、ponse within 60 days(Level 1)or 120 days(Level 2)PDEV Meeting Falls under will or may grant situation Multiple or multi-disciplinary questions New information,data,or questions not suitable for a CC Response within 120 days of PDEV being grantedDo not submit the same questions through a CC and PDEV