Stand Up and Be Counted-Or Raise Your Hand, or Hit Your Button

FDA is implementing simultaneous voting procedures for its advisory committees to help eliminate the potential for bias during deliberations. It doesn't look like everyone got the memo.

Arriving at the advisory committee review for Astellas Pharma Inc. and Cardiome Pharma Corp. ’s vernakalant (Kynapid) in December 2007, panel members found a new toy next to their microphone and tented name card: an electronic device in the shape of a small calculator.

The device, they were told, would be used at the end of the day-long meeting to record the committee’s votes. FDA was implementing new voting procedures under which members would...

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