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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 View Biography
Daniel Francis Donovan View Biography
Beverly Lorell
Seth H. Lundy View Biography
Jessica Ringel View Biography
King & Spalding LLP View Firm Credentials
Washington Office

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.


 

The views expressed in this document are solely the views of the author and not Martindale-Hubbell. This document is intended for informational purposes only and is not legal advice or a substitute for consultation with a licensed legal professional in a particular case or circumstance.


 

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