Module 1 2021

Special Protocol Assessment (2)

• For clinical study requests, request for SPA to be submitted at least 90 days prior to the anticipated start of the study • Additional documents (e.g., Statistical Analysis Plan [SAO],Charters, CRFs) • Process: – FDA review = 45 days – FDA could request for outside consultation with an advisor committee member or an advisory committee meeting – Sponsor can request a Type A meeting after receiving FDA feedback – If agreement is not reached, need to submit new SPA

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Advisory Committees

• Public meetings to review: – New NDAs, BLAs, new indications for approved products – New guidelines relating to therapeutic areas – Development issues during INDs (closed session if proprietary information discussed) – Background materials and minutes publicly available

• Non-FDA Members generally academic, mainly MDs plus statisticians and consumer representatives

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