Guidance for Industry and FDA on Pediatric Expertise for Advisory Panels; Availability

Resumen

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Pediatric Expertise for Advisory Panels; Guidance for Industry and FDA." The guidance defines pediatric subpopulations by age and specifies when we would seek pediatric expertise on our advisory panels. This guidance document is immediately in effect, but it remains subject to comment in accordance with the agency's good guidance practices (GGPs).