Changing The Amyloidosis Drug Development Pathway: Guidance For The FDA



Under the guidance of the U.S. Food & Drug Administration (FDA), the Amyloidosis Research Consortium (ARC) is convening a public patient and expert forum to stimulate increased understanding of amyloidosis. 
Building on ARC’s successful scientific roundtable meeting in mid-September 2015, the policy forum is the second step in the framing of draft guidance on amyloidosis drug development to be submitted for review to the FDA.  ARC will ensure that all discussions and related policies are not only grounded in science but also reflect innovative approaches that address patients' and families' experiences and needs.

Changing The Amyloidosis Drug Development Pathway: Guidance For The FDA
November 16, 2015
9:00 a.m.  to  3:00 p.m.
DoubleTree Hotel
Silver Spring, MD

The ARC and the FDA are committed to the success of this meeting. 


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View the Webcast

The entire event can be watched below. 


What is the purpose of this policy forum?
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Travel and registration details?
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We look forward to this important meeting and we hope to see you there.  Please confirm with us if you are going to join us and let us know if you have any questions. 

Share your story

We are compiling written patient and caregiver experiences to share with the FDA. The deadline for submitting stories is November 20th, 2015.

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Making the most of the FDA Patient Forum

We are pleased to be able to share the slides from the webinar presentation by James Valentine. James gave a comprehensive overview of drug development and the role patients can play in the Patient Focused Drug Development Meetings.

James worked in FDA’s Office of Health and Constituent Affairs (previously Office of Special Health Issues) where he facilitated patient input in benefit-risk decision-making and served as a liaison to stakeholders on a wide range of regulatory policy issues. James administered the FDA Patient Representative Program, facilitated stakeholder consultations during the reauthorization of PDUFA and MDUFA, launched the Patient-Focused Drug Development program, and developed the FDA Patient Network. 

View the slides