21st Century Cures Act as it Impacts the Rare Disease Community
(Kelly Austin, PhD, Sandra K. Heibel, PhD, and Marlene E. Haffner, MD, MPH)
National Institute of Health (NIH),
Office of Rare Diseases
National Organization for Rare Diseases (NORD)
US Food and Drug Administration / Orphan Drug Act
2009 interview with
Marlene E. Haffner, MD, MPH
2006 Nature Publishing
Group article
International Conference
on Rare Diseases
"FDA works to speed up
'orphan drug' process"
by Lorna Benson,
Minnesota Public Radio (see below)
Haffner Associates, LLC
Welcome to the website of Haffner Associates, LLC. We are delighted you found your way here and hope that we have the expertise for which you are looking.
Haffner Associates was founded in 2009 by Marlene Haffner, MD, MPH, former Director of the Office of Orphan Products Development at the Food and Drug Administration (FDA). As a company, Haffner Associates is dedicated to facilitating the development of therapies for the diagnosis, treatment and prevention of rare and devastating diseases – orphan diseases. Products for rare diseases are not easy to develop. Assisting pharmaceutical and biotechnology companies, working with regulatory agencies around the globe, finding patients, working with consumer support groups, and understanding “FDA think” are all part of a day’s work at Haffner Associates.
As a company Haffner Associates specializes in working with -
Biotechnology and pharmaceutical companies of all sizes and stages to:
Patients and patient advocacy groups to:
If you have a problem or question concerning rare diseases and/or developing a drug to treat a rare disease, Haffner Associates is the place for you to come to have your questions answered or your issues addressed.