Totality Of ‘Breakthrough’ Evidence Guides FDA Designation Decisions

Sponsors should think about more than just a single efficacy data point when assembling their designation requests because the agency looks at the ‘entire puzzle’ in deciding whether ‘breakthrough’ status is warranted.

FDA’s Center for Drug Evaluation and Research decides whether to grant or deny “breakthrough therapy” designation requests based on the totality of evidence available for a product, not any one efficacy data point, agency officials said April 24.

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