TREAT Act Wants Accelerated Approval Change, But Uses Existing Language
Anticipated legislation from Sen. Kay Hagan would copy federal regulations outlining accelerated approval to Food, Drug and Cosmetic Act, also encourage use of more broadly effective processes for expedited reviews.
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Letter being circulated by Rep. Bilirakis states the agency’s draft expedited approval guidance does not provide clarity for rare disease sponsors to use accelerated approval.
CDER’s Robert Temple says FDASIA mostly restates existing FDA authority, but also tells the agency it must better communicate what authority it has and how it will use it.
Comprehensive guidance document is expected to describe FDASIA changes and clarify terms that have become confusing as more pathways emerge to speed drug approvals.