, /PRNewswire/ -- The EveryLife Foundation for Rare Diseases commends the Food and Drug Administration (FDA) on today's announcement of its intention to create a . Co-chaired by CDER Director, Dr. , and CBER Director, Dr.
, the Hub will directly engage patients and the public to inform its strategic agenda. Most importantly, the Hub will provide a single point of contact within the Agency, a newly created position in the Director of Strategic Coalitions, to ensure streamlined engagement, consistency, and coordination across both Centers. "We are grateful for the continued leadership of Commissioner Califf, along with Dr.
and Dr. Patrizia Cavazonni, in recognizing the unique needs of the patients we represent," said , CEO of the EveryLife Foundation for Rare Diseases. "A more deliberate approach that includes a single point of contact to coordinate efforts across all Centers will be instrumental in bringing rare disease therapies to patients faster.
" Since convening a Scientific Workshop on the topic in 2018, EveryLife Foundation has been advocating for the creation of an inter-center institute for rare diseases at the FDA, i.e. a Center for Excellence for Rare Diseases, to serve as the FDA's coordinating office for engagement with rare disease stakeholders across all therapies including drugs, cell and gene therapies, and medical devices.
These efforts were bolstered by the leadership of the Congressional Rare Disease Caucus and its co-chairs, Representatives (R-FL) and (D-CA.