FDA issues draft guidance on Patient-Focused Drug Development: Methods to Identify What Is Important to Patients

FDA issues draft guidance on Patient-Focused Drug Development: Methods to Identify What Is Important to Patients

Today the U.S. Food and Drug Administration (FDA) issued a draft guidance on Patient-Focused Drug Development: Methods to Identify What Is Important to Patients; Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders . This guidance (Guidance 2) is the second in a series of guidance documents that FDA is developing to describe, 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 to be used for medical product development and regulatory decision-making. Guidance 2 describes methods to identify what matters most to patients regarding burden of disease and burden of treatment to guide medical product development, including endpoint development.

Interested parties are encouraged to submit comments on this draft guidance through the associated docket (FDA-2019-D-4247). For more information on the Center for Drug Evaluation and Research’s Patient-Focused Drug Development program please visit our website.