Attorney: Combo Review Issues Signal Hurdles For FDA Intercenter Institutes

December 16, 2016 at 2:17 PM
An industry attorney says FDA's challenges with combination products suggest the creation of new disease-specific intercenter institutes, as called for by the 21st Century Cures law, could slow down reviews. FDA Commissioner Robert Califf recently indicated the agency is mulling how to reorganize around diseases. Language in the recently signed Cures bill requires FDA to establish one disease-specific intercenter institute within a year of Cures enactment. “The Secretary shall establish one or more Intercenter Institutes within the Food and Drug...

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