“Approval Studies Do Not Have Enough Patients?”

By Ed Silverman // March 21st, 2013 // 11:06 am-Pharmalot
“The clamor for additional or lengthier studies to detect safety signals often prompts rejoinders that such efforts would not only lengthen the amount of time before a medicine could hit the market, but also adds to the development cost, which would be passed along to purchasers. Just the same, a new study indicates the number of patients needed to study chronic use in the European Union is insufficient to evaluate safety and long-term efficacy.”

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