Narcolepsy selected for FDA’s Patient-Focused Drug Development Initiative
The Food and Drug Administration (FDA) has announced the selection of 20 disease areas to be addressed during the first three years of its Patient-Focused Drug Development Initiative (PFDDI). Narcolepsy is one of the diseases that has been selected!
The goal of PFDDI is to obtain patient perspectives on certain disease areas in order to provide context for the FDA’s review of applications for new drugs in these disease areas.
The FDA selected the 20 disease areas based on a set of selection criteria, the perspectives of the reviewing divisions at FDA, and public input received on a preliminary set of 39 disease areas. After reviewing all criteria and comments, the list was narrowed to the final 20.
Almost 4,500 comments addressing more than 90 disease areas were submitted by patients and family members, patient advocacy groups including Narcolepsy Network, healthcare providers, and others. The majority of comments were submitted by individual patients, and over half of the comments received concerned three areas: lung cancer, narcolepsy, and interstitial lung disease.
NN worked with author and narcolepsy advocate Julie Flygare to rally members and supporters to comment about narcolepsy, and we thank Julie and everyone who came forward for raising their voices. Read more about Julie’s experiences with the selection process on her website.
The FDA will hold public meetings to gather patient perspectives, and meetings related to narcolepsy are tentatively scheduled for September 2013. For more information on the initiative, and the meeting schedule, visit the FDA website.
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Date Created: April 16th, 2013
Last Updated: April 16th, 2013