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The F.D.A.'s review process provides a rigorous regulatory framework for determining the safety and effectiveness of new medical devices, while facilitating innovation that leads to improved treatment options for American patients.
For such approaches to work in routine practice, the development of correspondingly complex biomarker assays through an appropriate and rigorous regulatory framework will be required.
Similar(58)
Breast augmentation surgery has been "trivialised", Dickson believes, and the regulatory framework that certified PIP devices as safe was not rigorous enough.
We decided to change the regulatory framework.
The regulatory framework had deficits too".
We will build a regulatory framework which encourages this".
John Penrose has sensible ideas about reforming the regulatory framework.
But getting the regulatory framework right is hard.
"There is a real need for an international regulatory framework.
He also pledged to overhaul the regulatory framework.
This is what happens without a proper regulatory framework".
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