The FDA announced a two-day public workshop to discuss Patient Focused Drug Development on October 15-16th at their White Oak Campus in Maryland. The meeting is being held to gather public feedback to create patient-focused drug development guidance as required by the 21stCentury Cures Act of 2016. The meeting will focus on these topics to help develop Guidances 2 and 3 (of 4 total):

• Methods to identify what is important to patients with respect to burden of disease, burden of treatment, and the benefits and risks in management of the patient’s disease
• Best practices for eliciting information on which aspects of disease symptoms, signs, impacts and other issues are important and meaningful to patients
• Measuring symptoms, signs, impacts and other issues of a disease or condition in a meaningful way
• Selecting, developing or modifying fit-for-purpose clinical outcome assessments (COAs) to measure the patient experience in clinical trials

Patients, patient advocates, academic and medical researchers, expert practitioners, drug developers, and other interested persons are invited to attend this meeting either in person or on the live webcast (register here) or to submit comments on the public docket here. Read more about the agency’s plans for Patient Focused Drug Development guidance here.

Text Copyright © 2018 Katrina Rogers