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

Streszczenie

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry, researchers, patient groups, and FDA staff entitled "Meetings with the Office of Orphan Products Development." This 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 guidance document is intended to assist these groups with requesting, preparing, scheduling, conducting, and documenting meetings with OOPD. This guidance finalizes the draft guidance of the same title dated April 2014.