Tag: Section 505A
Pediatric Exclusivity: How the FDA Extends Market Protection Without Changing Patent Dates
Pediatric exclusivity gives drugmakers six extra months of market protection after completing pediatric studies, even if their patent has expired. It doesn't extend the patent-it blocks generics from being approved by the FDA. This rule has shaped how drugs reach children and how generics enter the market.
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GMP for Generics: FDA Requirements for Manufacturing
Dec, 17 2025
