Posts Tagged ‘FDA’
Narcolepsy selected for FDA Patient Focused Drug Development Initiative (PFDDI)
I’m thrilled to announce that NARCOLEPSY has been selected for FDA’s Patient-focused Drug Development Initiative (PFDDI). Narcolepsy has been selected as one of the initial 12 disease areas for individual evaluation to be addressed in FY 2013 – FY 2015. We did it! I testified in person and led the campaign for online comments.…
Read MoreA Note of Thanks & FDA Update
This Thanksgiving, I’m grateful for your support. FDA Update:Last month, I launched the campaign for narcolepsy’s inclusion in the FDA Patient Focused Drug Development Initiative, but I could not do this alone. I’m thrilled to report that we came together as a unified voice in support of narcolepsy. By my unofficial count, a few HUNDRED…
Read MoreRepresenting People with Narcolepsy at the FDA
Yesterday, I had the extraordinary honor of visiting the Food and Drug Administration (FDA) to urge them to include Narcolepsy in the ground-breaking Patient-Focused Drug Development initiative. I was #19 to sign up on the disease nomination speaker list, even though I arrived 15 minutes before registration technically opened. The large conference room quickly filled…
Read MoreJoin me: Urge FDA to include Narcolepsy in new patient-focused initiative
The Food and Drug Administration (FDA) has nominated “narcolepsy” for a groundbreaking new patient-focused drug development initiative. Only 20 diseases will be chosen. Please join me in urging the FDA to select “narcolepsy” for this important effort. About the FDA Initiative:“Narcolepsy” is one of 39 disease areas nominated for a new FDA initiative to better inform the FDA’s drug and…
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