PeDRA Position Papers
PeDRA advocates for better access to treatments for children with dermatology diseases. Read PeDRA’s position statement submitted to the FDA on patient-focused drug development for alopecia areata: PeDRA position on alopecia areata drug development and the National Alopecia Areata Foundation’s statement: NAAF position on alopecia areata drug development
PeDRA advocates for better access to treatments for children with dermatology diseases. Read PeDRA’s position statement submitted to the FDA on patient-focused drug development for psoriasis: PeDRA position on psoriasis drug development.
The FDA has announced publication of the Psoriasis Voice of the Patient report that summarizes patient input from the March 17, 2016 FDA Patient-Focused Drug Development meeting on psoriasis. PeDRA clinician-investigators made comments at the meeting, as did a PeDRA pediatric patient, and provided the psoriasis position statement referenced above. The FDA report can be found here: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm368342.htm.
In 2015, PeDRA testified at an FDA hearing on developing atopic dermatitis systemic treatments for children. In addition to testifying, PeDRA developed a position statement, endorsed by several organizations, supporting the inclusion of children in appropriate clinical trials for these treatments. Read the position statement here.
In 2015, PeDRA provided leadership with the NIH on the question of advantages in using a central IRB for multisite studies. The PeDRA position outlined how a central IRB can eliminate redundant work efforts, streamline research and encourage collaborative work. Read PeDRA’s position statement here