Posted at February 28, 2014 5:08 pm by Mary Dunkle
The Food and Drug Administration’s Office of Orphan Products Development (OOPD), in collaboration with the FDA Center for Drug Evaluation and Research (CDER), has launched a web-based educational tool for rare disease patients, advocacy groups, researchers and industry on various FDA-related topics. read more >
Posted at January 22, 2014 7:11 pm by Leleah Robinson
Leleah Robinson, NORD’s Special Assistant to the Vice President of Public Policy, recently attended the FDA public workshops. This blog provides her insight into that event.
In July 2012, President Obama signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA) which requires the FDA to hold at least one public meeting to “encourage and accelerate the development of new therapies for pediatric rare diseases”. read more >