COPD Patient-Reported Outcome Questionnaire Is Early Example of FDA Drug Development Tool “Approval” Process

FDA finalizes the "qualification process for drug development tools." The topic won't get as much attention as Breakthrough Therapy or Accelerated Approval, but the head of the drug center thinks this is a very big deal. A COPD outcomes assessment is an early example of the process in action.

The Center for Drug Evaluation & Research publishes a lot of guidances over the course of a year. Some are announced with great fanfare, most draw little attention outside of the directly affected product category, and a few may generate more attention than FDA wished.

But on January 6, FDA finalized a guidance that CDER Director Janet Woodcock has publicly said deserves a lot more...

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