PDUFA VII Already: Could Breakthrough Ideas Apply Outside Program?

Success of enhanced communications in particular made one stakeholder wonder whether FDA could use it with non-breakthrough applications.

The success of the breakthrough therapies program has stakeholders wondering whether some of its tenets could be applied more broadly.

It is a question that likely will come down to FDA's ability to handle the additional work, but given the success of the breakthrough program, there likely will be a push from industry and

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