Comparative Observations

From the same consultation in Europe, comparative observations upon the regulatory frameworks in the EU and United States have revealed a perception that the EU is taking a more risk-adverse approach to assessment as compared with the FDA's policy of risk management. Specific instances would exist where products were removed, or threatened with removal, from the EU market because of perceived safety concerns, while the same products were dealt within the United States by the imposition of specific warnings in the label [21]. Comments were made about a similar level of conservatism in the EU in the approach to the review of products in specialist areas such as oncology and a greater willingness to embrace new therapies in the United States [21].

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