Webinar Preview: Perspectives on the FDA’s 2nd Patient-Focused Drug Development Guidance

June 10, 2019

By Maddie Mason, Associate, Policy

On Friday, Dec. 13 from 2 – 3 p.m. ET/ 11 a.m. – noon PT, the National Health Council (NHC) and our member organizations will present a webinar on the Food and Drug Administration’s (FDA’s) second draft guidance in their series on patient-focused drug development (PFDD). To receive the dial-in information, please click here to register.

The Center for Drug Evaluation (CDER) issued the second guidance and described it as the second “in a series of four methodological PFDD guidance documents that FDA is developing 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. Comments on the guidance are due December 30, 2019.

The NHC is a long-time supporter of bringing the patient perspective to medical product development, and we are excited by the FDA’s series of guidances for industry to further the science of patient engagement. We are hosting this webinar to help educate our members who wish to submit comments better understand the guidance. Our comments are based on a series of interactions with members to learn their perspective on the guidance, two of whom will also present on the webinar.

This webinar will consist of three presenters who will share their perspective on the guidance. Presenters include Elisabeth Oehrlein, PhD, MS, Senior Director, Research & Programs, NHC and Leslie Ritter, MA, Senior Director, Advocacy, National Multiple Sclerosis Society. A third presenter from industry will be announced closer to the webinar release date. The presenters will be moderated by the NHC’s Executive Vice President, Eleanor Perfetto, PhD, MS.

If you have any questions about the upcoming webinar, please contact Maddie Mason.