Tag: Hatch-Waxman
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FebruaryPediatric Exclusivity: How the FDA Extends Market Protection Without Changing Patents
Pediatric exclusivity gives drugmakers six extra months of market protection after completing FDA-requested pediatric studies. It doesn't extend patents but blocks generic approvals, creating a powerful regulatory tool that improves children's drug safety.
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Pediatric Exclusivity: How the FDA Extends Market Protection Without Changing Patents
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