FDA, EUROPEAN COMMISSION, EMEA AGREE TO INTENSIFY COOPERATION
July 1st, 2007
BY KEITH NUTHALL THE UNITED States Food and Drug Administration (FDA), the European Commission, and the European Medicines Agency (EMEA) have agreed to expand their current cooperation. They will intensify coordinated work on assessing paediatric and orphan medicines, while widening the organisations' scientific consultation to include extensions of therapeutic indications and risk management plans. An 'implementation plan' on transatlantic medicines regulatory cooperation has been revised to better describe what information will be shared and under what ...
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