FDA Must Codify Flexibility For Rare Diseases, Coté Says As He Moves To NORD
FDA needs to formalize the flexibility it has employed in its rare disease program, according to Tim Coté, the National Organization for Rare Disorders’ new Chief Medical Officer and former head of the agency’s orphan products development program.
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Georgetown, Maryland gain CERSI grants in part because of their proximity to agency staff.
Among other timetables set as part of the broad deal with industry, FDA will host meetings and issue guidances to assess and minimize the burden of REMS on the practitioners and patients.