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Archives for: December 16th, 2016

Reflections on FDA Listening Session

Written by abima2000 on December 16, 2016

fdaEarlier this week, I attended a listening session with the Commissioner of the FDA, Dr. Robert M. Califf. As a new employee in the NORD Policy Office, this was my first meeting at the FDA, and as such I was… Read More

Alpha-1 Patient Focused Drug Development Meeting

Written by Christina Jensen on September 29, 2015

The purpose of this Patient-Focused Drug Development meeting is to obtain input on the symptoms and other impacts that matte most to patients with AATD. FDA also intends to seek patients’ perspectives on current approaches to treating this disorder. FDA expects that this information will come directly from patients, caregivers,… Read More

Orphan Drug Act at 30: Will Success Become Too Expensive?

Written by Steven A. Grossman on January 19, 2013

Reprinted with permission from FDA Matters:  By Steven Grossman

The Orphan Drug Act (ODA) turned 30 this month, demonstrating that good laws really can have an enduring impact.  Amidst the celebrations, a reporter asked me a provocative question:  Can we afford more orphan drugs costing hundreds of… Read More