PURPOSE AND SCOPE OF MEETING. These meetings shall be held to review and discuss problems, practices, poli- cies and other matters of concerns.
PURPOSE AND SCOPE OF MEETING. The purpose of this Patient-Focused Drug Development meeting is to obtain input on the symptoms and other impacts of idiopathic pulmonary fibrosis that matter most to patients, as well as perspectives on current approaches to treating idiopathic pulmonary fibrosis. FDA expects that this information will come directly from patients, caregivers, and patient advocates. Idiopathic pulmonary fibrosis is a rare and life-threatening disease in which lung tissue become scarred over time. Many people with idiopathic pulmonary fibrosis survive only 3 to 5 years from the time of diagnosis. Symptoms of idiopathic pulmonary fibrosis can include shortness of breath, dry cough, fatigue, and chest pain. There is no cure for idiopathic pulmonary fibrosis; symptomatic treatment options include corticosteroids, oxygen therapy, pulmonary rehabilitation, and lifestyle changes. The questions that will be asked of patients and patient stakeholders at the meeting are listed in this section, organized by topic. For each topic, a brief initial patient panel discussion will begin the dialogue. This will be followed by a facilitated discussion inviting comments from other patient and patient stakeholder participants. In addition to input generated through this public meeting, FDA is interested in receiving patient input addressing these questions through written comments, which can be submitted to the public docket (see ADDRESSES).
