Expert urges FDA to name "pediatric ombudsman" within device unit

12/29/2009 | Clinica (subscription required)

The FDA must create the position of "pediatric ombudsman" within the agency's device center to assist companies in seeking regulatory approval for medical devices designed for children, said Tara Federici, AdvaMed's vice president for technology and regulatory affairs. The recommendation is in response to the agency's call for comments on clinical trials of pediatric devices.

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