Seeking to accelerate pediatric drug development, FDA offers guidance on requirements of two pivotal laws

It’s been two decades since the passage of two pivotal laws which created a new foundation for pediatric clinical testing in the U.S., the Pediatric Research Equity Act (PREA) and the Best Pharmaceuticals for Children Act (BPCA). But while the requirements may be old, FDA apparently feels that companies are too often failing to meet its requirements – or are just failing to meet them efficiently. Now the agency has revised and expanded a guidance document from 2005 into two separate documents which may serve to help sponsors meet their pediatric testing obligations more easily.

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