BioCentury
ARTICLE | Politics & Policy

FDA, NORD to include patient input in Orphan discussions

February 26, 2018 11:42 PM UTC

FDA unveiled several initiatives to help drive development of rare disease treatments, including a deal with the National Organization for Rare Disorders to integrate patient experience into regulatory discussions, according to a blog post by FDA Commissioner Scott Gottlieb.

Under the memorandum of understanding, FDA's Patient Affairs Staff and NORD plan to pilot listening sessions with patients on rare diseases to help guide clinical and regulatory understanding of diseases and conditions; gather a common understanding of the most urgent patient needs; and inform drug development programs...