FDA releases Video and Transcript of Meeting on Alpha-1
The U.S. Food and Drug Administration (FDA) has posted video footage and a full transcript of its Sept. 29, 2015 public meeting to discuss Patient-Focused Drug Development for Alpha-1 Antitrypsin Deficiency (Alpha-1).
Some 250 people packed the room at the FDA headquarters in Silver Spring, MD in September to share with the agency how Alpha-1 has impacted their lives. Another 600 participated via a live webcast that offered a chance to comment or ask questions.
The FDA’s Patient-Focused Drug Development initiative is intended to gather patients’ perspectives on the impact of a condition on daily life and the available therapies to treat that condition. The Alpha-1 community is one of just 20 scheduled over five years for these FDA hearings.
Currently, there is no cure for Alpha-1. When a treatment that may cure Alpha-1 is developed, it will require the FDA’s approval.
To read more about the meeting, click here.
To read the press release, click here.
(This article was published and provided by the Alpha-1 Foundation)