On September 24, 2012, the Food and Drug Administration (FDA) published two notices in connection with its patient-focused drug development initiative. The first notice announces a public meeting and an opportunity for public comment related to the initiative, and the second notice requests that patient stakeholders notify FDA of their intention to participate in periodic consultation meetings on process issues related to the initiative. By way of background, under the Prescription Drug User Fee Act, FDA must meet standards related to enhanced patient representation in drug regulation decision-making. The patient-focused drug development initiative fulfills this requirement. Under this initiative, FDA will conduct public meetings to consider 20 different disease areas. The first of these meetings, at which FDA will provide an overview of the initiative, will be held on October 25, 2012. Attendees will be invited to comment on FDA’s preliminary list of nominated diseases for the initiative and the criteria used to develop the list. The registration deadline is October 18, 2012, and comments may be submitted by November 1, 2012. In addition to public meetings to consider disease areas, FDA will hold meetings with patient stakeholders to discuss key process questions for patient-focused drug development. The deadline for stakeholders to notify FDA of their intention to participate is October 3, 2012, and the first meeting will be held on October 10, 2012.