The FDA is trying to engage more patients at earlier stages of the agency's decision-making processes, asking for patient input not only on drug approvals but also on clinical trial design, unmet medical needs, and the utility of new drugs and devices. "When it comes down to final decision, we want input on what risk patients are willing to tolerate to get the benefits," said James Valentine, program manager at the FDA Office of Health and Constituent Affairs.
FDA seeks more patient input
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