The Committments: Part I

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  • 04/11/2013

Here's the Federal Register notice announcing the 12 disease areas that have been selected by FDA for the PDUFA V patient-focused drug development meetings in FY2013-2015.

SUMMARY: The Food and Drug Administration (FDA) is announcing the selection of disease areas to be addressed during the first 3 years of Patient-Focused Drug Development. This 5-year initiative is being conducted to fulfill FDA’s performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). It provides a more systematic approach for the Agency to obtain patients’ input on specific disease areas, including their perspectives on their condition, its impact on daily life, and available therapies. FDA selected these disease areas based on a set of selection criteria, the perspectives of the reviewing divisions at FDA, and the public input received on a preliminary set of disease areas published in the Federal Register on September 24, 2012.

FDA has selected the following diseases to be addressed in FY 2013–2015:

* Alpha-1 antitrypsin deficiency;

* breast cancer;

* chronic Chagas disease;

* female sexual dysfunction;

* fibromyalgia;

* hemophilia A, hemophilia B, von Willebrand disease, and other heritable bleeding disorders;

* HIV;

* idiopathic pulmonary fibrosis;

* irritable bowel syndrome, gastroparesis, and gastroesophageal reflux disease with persistent regurgitation symptoms on protonpump inhibitors;

* lung cancer;

*  myalgic encephalomyelitis/chronic fatigue syndrome;

* narcolepsy;

* neurological manifestations of inborn errors of metabolism;

* Parkinson’s disease and Huntington’s disease;

*  pulmonary arterial hypertension;

* sickle cell disease




Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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