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Regulatory Focus™ > News Articles > US Pediatric Developments

US Pediatric Developments

Posted 01 March 2008

The history leading up to the US Best Pharmaceuticals for Children Act and Pediatric Research Equity Act, which were both recently renewed in the Food and Drug Administration Amendments Act of 2007, is very complex. Companies must be aware of the provisions of each of these pathways to incorporate appropriate pediatric programs that will provide meaningful information to the prescribing physician regarding the safe and effective use of their products in children.

 

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