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Scientists at Food & Drug Administration describe research in life sciences

Published in Medical Letter on the CDC and FDA, July 12th, 2009

"Plans for mass distribution of medical countermeasures raise challenging problems, including legal and regulatory issues," scientists in the United States report.

"Many in the distribution chain have expressed concerns over the potential for liability when countermeasures are distributed in accordance with large-scale response plans. This is of particular concern if the medical countermeasure involved has not been approved, cleared, or licensed by the US Food and Drug Administration (FDA)," wrote C. Maher and colleagues, Food & Drug Administration.

The researchers concluded: "This article discusses legal and regulatory options for countermeasure...

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