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Nat Rev Drug Discov 2016 Dec;15(12):805-6

Precision medicine and the changing role of regulatory agencies.

Breckenridge A, Eichler HG, Jarow JP

Abstract

The growth of precision medicine presents challenges for the regulators of medicines, related to aspects that include the basis of evidence generation, patient involvement in the regulatory process, cost of new medicines and the need for new regulatory models. It also raises questions about the tolerance of risk, especially with early interventions for life-threatening diseases.

Category: Journal Article, Editorial
PubMed ID: #27739512 DOI: 10.1038/nrd.2016.206
Includes FDA Authors from Scientific Area(s): Drugs
Entry Created: 2016-10-16 Entry Last Modified: 2017-01-02
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