Draft Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan Products Development; Availability

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry, researchers, patient groups, and FDA staff entitled "Meetings With the Office of Orphan Products Development." This draft guidance provides recommendations to industry, researchers, patient groups, and other stakeholders (collectively referred to as "stakeholders") interested in requesting a meeting with FDA's Office of Orphan Products Development (OOPD) on issues related to orphan drug designation requests, humanitarian use device (HUD) designation requests, rare pediatric disease designation requests, funding opportunities through the Orphan Products Grants Program and the Pediatric Device Consortia Grants Program, and orphan product patient-related topics of concern. This draft guidance document is intended to assist these groups with requesting, preparing, scheduling, conducting, and documenting meetings with OOPD.