NEHI: Real-World Data Could Spur Innovation If Scientific Rigor Applied

NEHI: Real-World Data Could Spur Innovation If Scientific Rigor Applied

Lawmakers also included provisions in the House-passed 21st Century Cures Act that direct FDA to include "patient experience data" in its risk-benefit determinations for drugs and devices, and expand the types of RWE that can be used in postmarket surveillance to include registry data and...

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Veröffentlicht in:Inside CMS 2016-06, Vol.19 (25), p.28-27
1. Verfasser: Wilson, Todd Allen
Format: Artikel
Sprache:eng
Schlagworte:
Bills
FDA approval
User fees
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Zusammenfassung:Lawmakers also included provisions in the House-passed 21st Century Cures Act that direct FDA to include "patient experience data" in its risk-benefit determinations for drugs and devices, and expand the types of RWE that can be used in postmarket surveillance to include registry data and peer-reviewed articles.
ISSN:2164-7526