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First patient-focused drug development guidance released

The FDA released its first patient-focused drug-development guidance that offers information on what constitutes patient experience data as well as general considerations when collecting such data. The guidance is the first in a series of four that aims "to address, in a stepwise manner, how stakeholders (patients, researchers, medical product developers and others) can collect and submit patient experience data and other relevant information from patients and caregivers for medical product development and regulatory decision making."

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