We’re continuing to work on improving PDUFA to allow the FDA additional authority to include rare diseases in the Accelerated Approval Program.

After a very successful response from the patient community last week, today we are mobilizing organizations to show their support for allowing the FDA to include scientifically valid surrogate endpoints as part of their clinical trial end points.

The House PDUFA draft already includes this language, the Senate version does not include the language we are working with RDLA on efforts to change this.

We’ll keep you posted as we work to advance this policy on behalf of the rare disease community.