How FDA Disclosure Proposals Would Affect Industry

Law360, New York (May 25, 2010, 3:00 PM EDT) -- On May 19, 2010, the U.S. Food and Drug Administration's Transparency Task Force, chaired by Principal Deputy Commissioner Joshua Sharfstein, issued a report containing 21 specific proposals to improve agency transparency across a variety of agency activities. The proposals detail specific new disclosure practices that would expand the scope of documents, information and actions subject to release by the agency.

Of particular interest, FDA proposes to immediately disclose the filing of investigational drug and device applications, new product marketing applications (NDAs, ANDAs, PMAs and 510(k)s), and...
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