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Last week the Food and Drug Administration (FDA) held the first in a series of forums to be held twice a year with international regulators designed to provide information about U.S. drug regulatory processes and share perspectives on approaches to common regulatory and scientific challenges.
Representatives from many nations, including the 15 "focus" countries participating in the President's Emergency Plan for AIDS Relief participated in this initial forum.
Staff from FDA's Center for Drug Evaluation and Research and the Office of International Programs explained FDA's role in this Presidential initiative; discussed the science, technology, regulations and management processes used in evaluating pharmaceuticals in the U.S.; and heard about approaches used by their international colleagues.
The last day of the forum was specifically designed to address the questions and issues of the drug regulatory authorities in the 15 focus countries that are part of the President's Emergency Plan for AIDS Relief.
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