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This Week’s FDA’s Patient-Focused Drug Development (PFDD) Initiative Meetings

September 22, 2014



The FDA’s Patient-Focused Drug Development (PFDD) initiative has two meetings scheduled for this week:

•   September 22, 2014 – Hemophilia A, Hemophilia B, von Willebrand Disease, & other Heritable Bleeding Disorders

•   September 26, 2014 – Idiopathic Pulmonary Fibrosis (IPF).

PFDD History

The 5-year PFDD initiative is created with the objective to obtain and better understand a patient’s perspective about their disease and to get patient feedback on treatments. PFDD’s purpose is:

“ … 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.”

PDUFA V, signed into law in July 2012 as Title I of FDASIA, is for Fiscal Years (FY) 2013 – 2017. It is under Section 10 of PDUFA V, “Enhancing Benefit-Risk Assessment in Regulatory Decision-Making”, that the FDA is required to obtain patients’ perspectives for at least 20 diseases over 5 years, through public meetings.

PFDD is a great way for patients, families, and caregivers to express their feelings and opinions about their particular disease and everyday living, the impacts of the disease on themselves and others, and to provide feedback on current treatments. It is a great way to start a conversation between patients and the FDA. PFDD gives a voice to the patient. PFDD gives a platform to the patient stakeholder to give input on disease areas and the drug development process. PFDD is another forum for patient advocacy to interact with a drug regulatory agency – the FDA.

Please Note: FDA Official Logo from FDA website.

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