The Food and Drug Administration (FDA) published a proposed rule on October 19, 2011 that would amend the 1992 Orphan Drug Regulations that implement the Orphan Drug Act. The amendments proposed are “intended to assist sponsors who are seeking and who have obtained orphan drug designation of their drugs, as well as FDA in administering the orphan drug program.” The FDA will accept comments on the proposed rule until January 17, 2012. Reed Smith has prepared a client alert summarizing the proposed rule and discussing the potential impact of the proposal on the drug, biological product, and biotechnology industries. To read the full alert, click here.