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FDA Holds Second Transparency Task Force Public Meeting Including Issues Related to Disclosure of Clinical Trial Data by Edward M. Basile
King & Spalding LLP - Washington Office
Daniel Francis Donovan
King & Spalding LLP - Washington Office
Beverly Lorell
King & Spalding LLP - Washington Office
Seth H. Lundy
King & Spalding LLP - Washington Office
Jessica Ringel
King & Spalding LLP - Washington Office
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November 6, 2009
Previously published on November 5, 2009
On November 3, the U.S. Food and Drug Administration's (FDA or Agency) Transparency Task Force held its second public meeting. Principal Deputy Commissioner and Task Force leader Joshua Sharfstein stated that the Task Force's goal is to draft recommendations for FDA Commissioner Margaret Hamburg related to transparency. This process will take place in three phases: 1) development of an interactive FDA website; 2) recommendations related to Agency disclosure of information and bases for decisionmaking; and 3) recommendations concerning transparency towards industry. Once the Task Force releases its recommendations, there will be a period for public comment.
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