What is the official ID of this bill?
The official print number for this legislation is S 1132.
Faster Drug Approval: Relying on Foreign Safety and Efficacy Data.
This bill aims to speed up the availability of new prescription drugs for US citizens by allowing manufacturers to use clinical and safety data from investigations conducted in specific foreign countries where the drug is already approved. This mechanism could provide patients with quicker access to therapies already vetted and marketed in trusted jurisdictions. The FDA review timeline for these applications is significantly shortened to 90 days.
Key points
Accelerated Review Timeline: The FDA must decide on applications relying on foreign data within 90 days, significantly shortening the standard approval process.
Acceptance of Foreign Studies: Manufacturers can rely on safety and effectiveness data from studies conducted in trusted partner countries, including the UK.
New Expert Committee: A dedicated Foreign Drug Review Advisory Committee will be established to evaluate these applications, ensuring safety standards are maintained.
Status:
Expired
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