Families living with rare diseases will have a chance to tell the Food and Drug Administration how it should review treatments for small patient populations. The agency will hold a public meeting on Oct. 28 from 1 to 5 p.m. ET, both in person and online, as part of a new Rare Disease Framework Initiative announced Oct. 14.
Written comments will be accepted through Dec. 11 under docket number FDA-2026-N-12214. The FDA says the feedback will help shape new or revised guidance, possible regulatory changes, staff training, and organizational changes for rare disease drug and biologic reviews.
