FDA Approval Standards Need To Be Relaxed, Venture Capitalists Say
FDA should accept “a reasonable likelihood of patient benefit” as the appropriate standard for approving therapies for unmet medical needs, the National Venture Capital Association and its Medical Innovation & Competitiveness Coalition contend.
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The Senate measure adds a provision on breakthrough therapies and specifies that accelerated approval provisions do not alter substantial evidence standard used to approve drugs.
The deputy commissioner detailed the steps involved in getting Vertex’s cystic fibrosis drug rapidly through the approval process and noted that FDA is working on innovative study designs and assessing how to better use diagnostics.