Accelerated Approval Legislation Picking Up Speed; ULTRA Becoming FAST
This article was originally published in The Pink Sheet Daily
Revisions to the House bill make it nearly identical to sections of Sen. Kay Hagan’s legislation. The debate on PDUFA add-ons will be rejoined at a Commerce Committee hearing, but TREAT now has considerable momentum.
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The bill, some version of which is undoubtedly destined for the FDA user fee package, also would codify existing labeling guidance for products cleared through the pathway.
As Congress considers how to ensure downstream supply chain security, industry groups are looking at a process to link drugs to their manufacturer. But in a recent communication with the Senate HELP Committee, FDA backs a “comprehensive national track-and-trace system.”
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.