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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Congress Dives Into Biomedical Innovation: Will It Drown In A Deep Sea Of Competing Needs?
House Energy and Commerce committee says it’s committed to a bill to accelerate U.S. biomedical innovation before the next FDA user fee cycle, but the wide scope of needs and stakeholders may make crafting legislation challenging – never mind getting it passed.
Accelerated Approval Bill In Senate Tracks House Draft, But With More Of A Nod To FDA
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.
Innovative Drug Development: Kalydeco Provides A Paradigm, FDA’s Spielberg Says
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.