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Zdrowie i gospodarka · 09/04/2018

Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs; Draft Guidance for Industry; Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs." This draft guidance addresses FDA's current thinking about the relevant age groups to study and how early in the drug development pediatric patients should be incorporated during development of systemic drugs for atopic dermatitis (AD).

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