Global Regulatory Strategy

Posted 11 October 2016 By Prerna Menon

placeholder+image This article discusses the development of a regulatory strategy allowing companies to identify opportunities and problems prospectively, improve utilization of company resources and focus the development team on the key objectives and assist in developing products with a positive benefit-risk profile demonstrating differential advantages and value for prescribers and payers.

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Categories: Biologics and biotechnology, Drugs, Regulatory strategy, Submission and registration, Features, US, Canada, Europe, Japan, FDA, EMA, Health Canada, MHLW, PMDA

Tags: Priority Review, Accelerated Approval, Breakthrough Designation, Fast Track Designation, Conditional Approval, PRIME, Adaptive Licensing, Accelerated Assessment, Sakigake

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