Meindert Boysen, head of NICE’s Centre For Health Technology Evaluation, shares advice for companies aiming to get their medicine to patients. His golden rules: engage in early advice and be more realistic about pricing.
The stakes are extremely high for companies called before EU or US regulators and scientific experts to answer queries about their new drug applications at the later stages of the review process. Consultant Kate Dion highlights to In Vivo helpful tips for companies facing this daunting situation.
Three Brexit deadlines have come and gone, and the UK is still a member of the European Union. It will remain so until it agrees a withdrawal deal or leaves without one at the end of January 2020. Alternatively, it could secure yet another extension to the Article 50 period beyond January 31. Or it could decide not to leave at all.
The main priorities for the new chief executive of Japan’s drugs regulator over the next five years include putting patients first by promoting early access while ensuring safety, further strengthening pharmacovigilance as new forms of therapy come through, and increasing collaboration with Asia, as the agency looks to meet the challenges of changing technologies.
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