Lawmakers Push FDA To Clarify Special Protocol Assessment Rescissions

June 23, 2014 at 10:55 PM
Senate and House appropriators are pushing FDA to explain the standards it uses for rescinding drug special protocol assessment (SPA) agreements, as industry questions FDA's lack of transparency when changing these agreements. The congressional inquiry, part of report language accompanying agricultural funding bills, is backed by the Biotechnology Industry Organization. James Healy, a non-executive director at Amarin, Hyperion, InterMune and other private biotech companies, a general partner at Sofinnova Ventures and a member of the board of directors of the...


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