Porzio Life Sciences Enforcement Action Update: New FDA Guidance Examines Patient-Focused Drug Development

March 16, 2022

By Porzio Life Sciences

The U.S. Department of Health and Human Services of the Food and Drug Administration (FDA) has issued Guidance for Industry titled "Patient-Focused Drug Development: Methods to Identify What Is Important to Patients." The guidance is the second of four patient-focused drug development guidance documents.

The purpose and scope of the guidance is described as a means for eliciting information from individuals identified in Guidance 1 along with methods and best practices to be used in conducting qualitative research. The Agency notes that the guidance is not a detailed instruction guide or a substitute for contracting subject matter experts when pursuing the work described.

The Guidance covers qualitative, quantitative, and mixed methods for gathering research data to identify what is important to patients. Such methods include using one-on-one interviews, focus groups, and surveys to help ensure that patients’ experiences, perspectives, needs, and priorities are taken into account and incorporated into drug development and evaluation in a meaningful way. The Guidance also provides many examples of the varying research methods described, along with multiple appendices outlining additional research methods, considerations for selection of qualitative data collection, analysis of qualitative data, and screening and exit interview studies.

As noted by the Agency, the guidance is intended to only provide clarity to the public regarding existing requirements under the law, and does not have the force and effect of law, unless specifically incorporated into a contract.

A copy of the Guidance is available here.

For more information regarding FDA Guidance, please see the OPDP Promotional Violations section of the Enforcement Actions Database.

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