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FDA Clarifies Approach to Pediatric Drug Development | Sheppard Mullin Richter & Hampton LLP

On May 17, the U.S. Food & Drug Administration (“FDA”) issued two important draft guidance documents, which clarify the agency’s approach to requirements and incentives in the realm of. ....

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FDA Issues New Rules for Pediatric Drug Trials

FDA issued two new guidances on development and clinical trials of pediatric medications replacing 2005 rules. Pediatric drugs are developed slower difficulty clinical testing. Adult drugs can be used off label for children. New rules incentivize pediatric drug development. ....

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