Advocates Press For US FDA Rare Disease Center Of Excellence
Executive Summary
Attorneys' proposal aims to better connect dispersed rare disease expertise within FDA's drug, biologic, and device centers through more leadership, new advisory committee.
You may also be interested in...
New US FDA Genetic Metabolic Adcomm Needs More Candidates
Given the enthusiasm for the new advisory committee within the rare disease community, the need for an extended deadline is somewhat surprising. FDA has not yet determined when the chair and members of the new panel will be named.
Genetic Metabolic Diseases Get Their Own US FDA Advisory Committee
In a first for rare diseases, a new standing committee will provide advice and recommendations on technical, scientific and policy issues related to medical products for genetic metabolic diseases.
Rare Disease Advocates Lobby US Congress For FDA Center of Excellence
Number one ask is for congressional pressure to centralize rare disease expertise at the agency, but advocates also are preparing legislation that would mandate the new center.