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Regulatory Cooperation Expanded between FDA, EC and EMEA
The US Food and Drug Administration (FDA), the European Commission (EC), and the European Medicines Agency (EMEA) have agreed to expand their current cooperative activities in several important areas. At a meeting June 14-15, 2007, the FDA and the EU reviewed the past year's activities under the existing Implementation Plan for the confidentiality arrangement. The ultimate goal of the initiative is to promote and protect public health, reducing regulatory burden and costs, and bringing innovative products to patients in a timely manner. Furthermore, important safety information about medicinal products is shared among the parties.
Building on the achievements in cooperation on vaccines, oncology, and pharmacogenomics, it was agreed to expand further the interactions in the areas of pediatrics and medicinal products for rare diseases ("orphan drugs"). Furthermore, scientific dialogue has been widened to include extensions of therapeutic indications and risk management plans. Based upon the newly adopted pediatric legislation in the EU, a "Principles of Interactions" document that will facilitate the timely exchange of information on scientific and ethical issues for pediatric therapeutics has been finalized.
click here for the full FDA text
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