FDA To Provide Expedited Approval Desktop Reference
Comprehensive guidance document is expected to describe FDASIA changes and clarify terms that have become confusing as more pathways emerge to speed drug approvals.
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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.
In its desktop reference guidance on the four expedited regulatory pathways, FDA broadens its view of when an investigational drug fills an “unmet medical need” and guides sponsors through the use of intermediate clinical endpoints as a basis for accelerated approval.
Draft guidance explains the four expedited drug development and approval pathways and offers the agency’s first formal advice on the type and amount of evidence needed for designation as a “breakthrough therapy” under FDASIA.