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Georgia: Report - FDA May Halt Avandia Safety Study

According to the Wall Street Journal report, FDA commissioner Margaret Hamburg wrote a letter to Grassley in late March saying that the agency is reassessing a trial that compares the drug to a drug made by Takeda Pharmaceutical Co called Actos. That trial is also called the TIDE trial, according to the Journal.

FDA Principal Deputy Commissioner Joshua Sharfstein told the Journal that the decision on the trial "cannot be de-linked from the agency's view of Avandia."

Sharfstein said no decision had been made on the trial -- the FDA has asked a government scientific panel to review the ethics of head-to-head trials, the Journal said.

Link here: http://online.wsj.com/article/SB10001424052748704508904575191944217066832.html?mod=WSJ_hpp_MIDDLENexttoWhatsNewsSecond

Full post as published by A Georgia Lawyer on April 18, 2010 (boomark / email).