Patient-Focused drug development: New FDA draft guidance

FDA is announcing the availability of a draft guidance for industry, FDA staff, and other stakeholders entitled “Patient-Focused Drug Development: Methods To Identify What Is Important to Patients.” This guidance (Guidance 2) is the second in a series of four methodological patient-focused drug development guidance documents that FDA committed to develop to describe how stakeholders (patients, researchers, medical product developers, and others) can collect and submit information from patients and caregivers to be used for medical product development and regulatory decision-making.

This series of guidance documents is intended to facilitate the advancement and use of systematic approaches to collect and use robust and meaningful patient and caregiver input that can more consistently inform medical product development and regulatory decision-making. The purpose of Guidance 2 is to present a range of methods and established best research practices to identify what is important to patients with respect to burden of disease, burden of treatment, and the benefits and risks in the management of the patient's disease. The methods and best practices presented can help elicit relevant information from patients and other stakeholders, such as how their disease affects their daily lives; what they find most troublesome; and the challenges, problems, and burdens of the treatment for the disease.

Visit the FDA website for more information and to download the Draft Guidance Document