Fact Sheet

Patient-Focused Drug Development

PhRMA June 9, 2016

Patient-focused drug development (PFDD) incorporates the patient’s voice in the development and the U.S. Food and Drug Administration’s (FDA) evaluation of new medicines. During clinical trials, researchers study whether new medicines are safe and effective for patients and whether the medicine’s benefits outweigh the risks. The FDA considers the benefit-risk assessment when making a decision on whether or not to approve a medicine for patient use.

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