Critical gaps found in pediatric medical device trials: Lack of control groups and low infant participation
Clinical trials addressing high-risk pediatric medical devices used in children.
Source: news-medical.net
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GAO Report Recommends Strengthening FDA Oversight Of FCSs - Food and Drugs Law
The U.S. Government Accountability Office (GAO) has issued a report critiquing the premarket authorization programs handled by the U.S. Food and Drug Administration (FDA).
Source: mondaq.com