Vital Transformation Study Examines New Proposals to Alter Accelerated Approvals

CBSA is committed to keeping our community updated on issues that impact life sciences. Our Policy + Advocacy team continues to monitor and review legislation that could directly affect life sciences companies in Colorado, including an FDA program designed to speed needed medicines to market.

What is the Accelerated Approval Pathway?

The Food and Drug Administration (FDA) Instituted an Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions and that fill an unmet medical need based on a surrogate endpoint. The use of a surrogate endpoint can considerably shorten the time required to receive FDA approval.

If a drug goes to market with accelerated approval, the manufacturer is still required to conduct studies to confirm the anticipated clinical benefit, known as phase 4 confirmatory trials. If the confirmatory trial shows that the drug provides a clinical benefit, then the FDA grants traditional approval for the…
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