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Zdrowie i gospodarka · 08/10/1999

Guidance for Industry on Qualifying for Pediatric Exclusivity; Availability; Revised

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance for industry entitled ``Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act.'' FDA is publishing this revised guidance to assist industry in interpreting provisions of the Food and Drug Administration Modernization Act of 1997 (Modernization Act). This guidance will remain in effect until superseded by regulations or new guidance.

Source: Federal Register — Food and Drug AdministrationOpen original release →