Department of Health and Human Services September 24, 2012 – Federal Register Recent Federal Regulation Documents
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Prescription Drug User Fee Act Patient-Focused Drug Development; Public Meeting and Request for Comments
The Food and Drug Administration (FDA) is announcing a public meeting and an opportunity for public comment related to FDA's patient- focused drug development initiative. This initiative is being conducted to fulfill FDA performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). This effort provides for a more systematic approach under PDUFA V for obtaining patient perspective on the disease severity and the currently available treatments for a set of disease areas. FDA is publishing a preliminary list of nominated disease areas for the patient-focused drug development initiative and the criteria used for nomination. The public is invited to comment on this preliminary list through a public docket and at a public meeting where FDA will provide an overview of the patient-focused drug development initiative with discussion of the nominated disease areas.
Prescription Drug User Fee Act V Patient-Focused Drug Development; Consultation Meetings; Request for Notification of Patient Stakeholder Intention To Participate
The Food and Drug Administration (FDA) is issuing this notice to request that patient stakeholders notify FDA of their intention to participate in periodic consultation meetings on process issues related to FDA's patient-focused drug development initiative. This initiative is being conducted to fulfill FDA performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). These periodic consultation meetings will address important considerations and challenges in establishing a process for conducting a series of patient-focused drug development meetings that will be useful to both the patient community and FDA. The purpose of this request for notification is to ensure continuity and progress in these discussions by establishing consistent patient stakeholder representation.
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