food and drug administration (fda)

What are Pediatric Exclusivity and Pediatric Rule?

The Pediatric Exclusivity provision offers an incentive for pharmaceutical companies to conduct studies in children by extending their market exclusivity. The Pediatric Rule mandates that certain new drugs and biologics be tested for their safety and effectiveness in children if the drug is likely to be used in pediatric populations. Together, these initiatives aim to improve the availability of safe and effective medications for children.

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