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Tag: pediatric exclusivity

Pediatric Exclusivity: How the FDA Extends Market Protection Without Changing Patents

2

February

Pediatric Exclusivity: How the FDA Extends Market Protection Without Changing Patents

  • Categories: Health
  • Comments: 14

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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