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Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety
Published on: September 15, 2023
Medicines regulation and health technology assessment
A Breckenridge1, K Woods, T Walley
1Medicines and Healthcare Products Regulatory Agency, London, UK. Alasdair.Breckenridge@mhra.gsi.gov.uk
Abstract:
Health technology assessment (HTA) is as important as regulation to allow patients access to new medicines, and there are demands that the two processes should be carried out more closely together in time. Although the methods used by the regulator differ from those used by the health technology assessor, there is scope for synergies that would be useful to both parties. By providing scientific advice to sponsors of new medicines, both regulators and health technology assessors can also provide support for drug innovation.
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