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FDA Responds to Nagging Questions About “Lagging” Drug Review Divisions

This article was originally published in RPM Report

Executive Summary

It’s a question FDA has heard on Capitol Hill throughout the 21st Century Cures process: Why can’t all drug review divisions keep pace with the approvals seen in the oncology office – and shouldn’t steps be taken to ease development pathways for “lagging” conditions like Alzheimer’s and rare diseases? In the face of a tougher “Cures” debate in the Senate, FDA issues a white paper to more fully outline its response.

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