Rare Disease Cures Accelerator Expected To Drive Lots Of Development – Eventually
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ICD Code Breaking: Rare Disease Advocates Want Simpler, Shorter Nomination Process
A group would look at the diseases that need codes and which to add initially, then consider updates to the code nomination process, in an effort to lower costs for rare disease patients.
Complex Generics: Pre-Competitive Research Collaborations To Get US FDA Funding Boost
Center for Research on Complex Generics will be similar to the Critical Path Institute; training sessions for industry could begin in January.
Rare Diseases And Beyond: FDA Seeks Input On Establishing Clinical Trial Networks
US FDA is looking for advice on how to design a clinical trial network to complete the third component of its Rare Disease Cures Accelerator Program, but it also wants advice on clinical trial networks more broadly. The rare disease network will need to be global given the more limited patient populations, the agency said.