Module 1 2021

FDA Meeting Process

• Give careful consideration to your selection of the proposed date(s) to optimize your choice • Consider the merits of Face-to-Face meeting versus Teleconference • Most division provide written feedback ahead of the F2F meeting • Attendees from company/advisors/experts/KoLs • Meetings are allocated 1 to 1.5 hours maximum – Use allocated time effectively with careful preparations/rehearsals – Summarize clearly the agreements and actions to avoid misunderstanding later • FDA’s minutes are official and binding version – Sponsor may submit minutes

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Special Protocol Assessment (SPA)

• Upon request, FDA will evaluate certain protocol and issues relating to the protocols to assess whether they are adequate to meet scientific and regulatory requirements identified by the sponsor

• Three types of protocol eligible: – Carcinogenicity protocols

– Final product stability protocols. – Clinical protocols for phase 3 trials

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