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Regulatory Focus™ > News Articles > FDA Requirements for Clinical Studies in Pediatric Patients

FDA Requirements for Clinical Studies in Pediatric Patients

Posted 01 June 2009

Differences in the physiology of adults and children can produce significant differences in the way they respond to drugs and vaccines. Without adequate data on pediatric safety and efficacy of many products, physicians until recently had to make decisions on their use in pediatric patients based upon labeling that only addressed use in adults.

 

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