The Food and Drug Administration is set to hold a public meeting on April 29 regarding “Patient Perspectives on the Impact of Rare Diseases: Bridging the Commonalities.”
The FDA wants public comments in order to help in the development of treatments for rare diseases. The FDA understands that rare diseases are hard to treat and have many differences, causing roadblocks in development. The goal of the meeting is to create trial designs that can be used across a wide variety of rare diseases. Topics scheduled to be discussed include commonalities in symptom management and treatment considerations and commonalities in clinical study considerations and registry considerations.
The public can submit comments, regardless of attendance, at regulations.gov or the Division of Docket’s Management (HFA-305), Food and Drug Administration, 5630 Fishers Ln., Room 1061, Rockville, Maryland. Comments must include docket number FDA-2019-N-0077.
The meeting will be held at the FDA’s White Oak Campus at 10903 New Hampshire Ave., Building 31 Conference Center, Great Room C, Silver Spring, Maryland. Non-FDA employees are asked to use the entrance to Building 1. Registration is online through Eventbrite or in-person.
