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IOM report suggests how to fix weaknesses in US paediatrics laws

This article was originally published in SRA

Executive Summary

A report by the Institute of Medicine has identified ways to strengthen the current US legislation for motivating or requiring pharmaceutical companies to conduct paediatric studies, including giving the Food and Drug Administration flexibility to impose sanctions for unreasonably delayed studies1.

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The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with three new products including Novartis's Beovu for treating neovascular (wet) age related macular degeneration. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).

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