Unsure About ‘Breakthrough’-Worthiness? Talk To FDA First

An early, informal conversation between a sponsor and the review division about the supportive data could help reduce the number of ‘breakthrough therapy’ designation requests that are ultimately denied, FDA and sponsors said.

Sponsors interested in seeking “breakthrough therapy” status should first consult their FDA review division to assess whether existing data potentially support designation under the expedited regulatory pathway.

Early consultation with agency reviewers would help reduce the number of requests that are ultimately rejected, saving the agency and...

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