User Fees at EMEA: The View From Across the Atlantic

Posted 01 February 2008 | By

It is not uncommon today for a small to mid-sized US pharmaceutical company, having achieved US Food and Drug Administration (FDA) approval for one or more of its products, to seek its first approval in the European Union (EU). Although European regulatory activities in this situation are often co-managed with international partners who have more extensive EU experience (either a CRO or licensee company), business realities may dictate that a regulatory professional with primarily US regulatory experience be responsible for developing a European regulatory strategy for the first time. For this reason, it is often important for US regulatory professionals to be aware of specific issues involved in successfully managing a drug application in the European system.

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