Posted by Michael Wonder on 29 Nov 2016
Precision medicine and the changing role of regulatory agencies
29 November 2016 - 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.
