- Disease areas that are chronic, symptomatic, or affect functioning and activities of daily living;
- Disease areas that reflect a range of severity;
- Disease areas for which aspects of the disease are not formally captured in clinical trials;
- Disease areas that have a severe impact on identifiable subpopulations (such as children or the elderly);
- Disease areas that represent a broad range in terms of size of the affected population; or
- Disease areas for which there are currently no therapies or very few therapies, or the available therapies do not directly affect how a patient feels, functions, or survives.
I thank the FDA for this opportunity to share views as a patient on the development of medications. I am a parent of two type 1 teens and a pre type 2 patient myself. We are just few of the over 25 million Americans that the CDC estimates live with diabetes. I urge the FDA to consider a wide perspective on diabetes in this PDUFA meeting process. Specifically I hope the FDA will dedicate one of the twenty planned disease topics to diabetes. That should include at all forms of diabetes and their related complications. Specifically diabetes should be viewed by its different types, Type 1, Type 2 LADA and gestational.