Data about FDA special protocol assessments might help public

02/9/2010 | Forbes

Though the FDA promised to be more transparent, legislation might be necessary to require the agency to disclose special protocol assessments with drugmakers, according to this blog. By making SPAs public, investors can become aware of the progress of drug trials, raising their confidence in their investments, the blog notes. Because the FDA treats SPAs as confidential, investors of Cell Therapeutics were unaware that the company's SPA was no longer valid, causing shares to drop 40% on Monday.

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