FDA Expedited Programs Guidance: “Available Therapies” Depends On U.S. Standard Of Care
Draft guidance explains the four expedited drug development and approval pathways and offers the agency’s first formal advice on the type and amount of evidence needed for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.
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US FDA's Search For Meaning: Interpretation Of Regulatory Language Can Inspire Conflict In Drug Reviews
The Pink Sheet's Drug Review Profile series illustrates the challenge of reconciling review realities and broad statutory directives.
Comprehensive guidance document is expected to describe FDASIA changes and clarify terms that have become confusing as more pathways emerge to speed drug approvals.
A few requests have gone to FDA for candidates to be named breakthrough therapies and gain access to shorter development programs, but the agency has not established all the program requirements yet.