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Regulatory News In Brief

FDA issues two FDASIA-mandated reports to Congress – one on underrepresented subpopulations and the second on small businesses. More regulatory news.

FDA issued a report to Congress on July 5 called “FDA Report Ensuring Access to Adequate Information on Medical Products for All With a Special Focus on Underrepresented Subpopulations, Including Racial Subgroups.” The report was due to Congress within one year after the July 2012 enactment of the FDA Safety and Innovation Act.

The report was written by a work group of representatives from FDA’s drug, device and biological medical products review centers. Their recommendations for improving communication with subpopulations include targeted outreach...

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