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Senators Let FDA Know Their Intent Regarding Data Exclusivity Provisions of PPACA

By Donald Zuhn, Kevin Noonan, Chris Singer, Sherri Oslick, and Jason Derry

By Kevin E. Noonan -- Members of Congress having sent their letter to the Food and Drug Administration on December 21st (see "Representatives Send Letter to FDA to Explain Data Exclusivity Provisions of Biosimilars Legislation"), on January 7th, it was the Senate's turn. In their letter, Senators Kay Hagan (D-NC), Orrin Hatch (R-UT), Michael Enzi (R-WY), and John Kerry (D-MA) address the same provisions of the Act and give the Agency substantially the same message as to their "intent" in passing the legislation that their House colleagues did two weeks earlier. Agency action that prompted the Senators' letter was the...

Full post as published by Patent Docs on January 12, 2011 (boomark / email).