FDA Releases Guidance on Patient-Centered Drug Development

A final draft guidance regarding patient-focused drug development (PFDD) has been issued by the US Food and Drug Administration (FDA). The guidance covers data collection methods about patient care experiences and how they can be used in regulatory decision-making processes, specifically clinical outcomes assessments (COA).

According to Ferdous Al-Faruque, “In line with recent legislation, FDA has published several guidances covering various aspects of patient-focused drug development, from collecting patient input to choosing and developing “fit-for-purpose” COAs. The latest guidance describes how stakeholders, including healthcare providers, researchers and sponsors can select and construct COA-based endpoints for use in clinical trials, as well as recommendations for evaluating the meaningfulness of results of COA-based endpoints and other study design considerations.”

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(Source: RAPS, April 5^th, 2023)