This is part one of a two part ISPOR webinar series. The FDA is developing Patient-Focused Drug Development (PFDD) guidance to inform the inclusion of patient experience when developing new medical therapies and products. This is a four-part guidance series, with two final guidances released, a third draft guidance released and a fourth guidance under development. The PFDD guidance is anticipated to be influential in the field of health economics and outcomes research. In this webinar series, we will hear from patients and FDA staff to learn what is covered in this guidance series and what these new guidances mean for patient-focused drug development.
FDA Patient-Focused Drug Development (PFDD) GuidanceC T2023-10-13T16:58:46-04:00
The political issues circling the FDA this year could potentially ripple into biopharma on a scale that’s never been seen before. All eyes are on the FDA’s response to recent court rulings around the abortion pill mifepristone — and the potential effects on other approvals that might be questioned. What does the future look like, exactly? Join Endpoints’ Senior Editor Zachary Brennan in an expert panel to unpack what may come next. We’ll also touch on how the FDA is looking for new ways to spur more rare disease drug development with a fireside chat.
Hear expert panelists bring their perspectives on critical issues around support for Medicare Part D products' fair market prices.
Join three panelists who will provide a practical overview of how and why to use data from Medicare for real world studies.