08 Jun Narcolepsy Is Selected for FDA’s Patient-focused Drug Development Initiative (PFDDI)
On April 11, the U.S. Food & Drug Administration (FDA) named narcolepsy one of the initial 12 disease areas selected for individual evaluation in FYs 2013-2015. The PFDDI will enable the FDA to gain patients’ perspectives as part of the FDA drug approval process.
WUN friend Julie Flygare testified before the FDA in October and spearheaded a campaign for online comments.
Monica Gow, WUN Executive Director, said, “Thanks to Julie and everyone who submitted comments, FDA officials did the right thing by including narcolepsy in the PFDDI.”
According to the agency, “Over half of the comments received concerned lung cancer, narcolepsy, and interstitial lung disease,” Read the FDA’s announcement.
FDA meetings are scheduled to begin in September to address matters such as how narcolepsy affects patients’ lives, and their perspectives on the adequacy of available therapies. These meetings will include the participation of FDA officials, narcolepsy sufferers, and other stakeholders.
Thank you everyone who helped with this initiative. Narcolepsy awareness is indeed on the march!