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Patient Community Is FDA’s “Guiding Light” On Acceptable Drug Risks

 
• By Brenda Sandburg

CDER’s Janet Woodcock says the community has the agency’s ear when it advocates new developments; cites need for an “adult conversation” in assessing when drugs should be made available to patients.

FDA is willing to listen to everyone affected by its decisions, but patient advocacy groups may get special recognition. That is the message Center for Drugs Evaluation and Research Director Janet Woodcock conveyed at the Partnering for Cures meeting in New York.

“We need to hear from the affected community what type of [drug side effect] tradeoffs they think are acceptable and that should be our guiding light,” Woodcock said. “We shouldn’t...

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