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Archives for: June 17th, 2014

Thoughtful Biosimilars Policy Is Best Way to Ensure Optimum Patient Outcomes

Written by on June 4, 2014

Biologic therapies have been lifesaving and life changing for the patients we represent – more than 30 million Americans with more than 7,000 rare diseases. Literally, hundreds of thousands of rare disease patients have found their lives bettered by biologics and we are collectively grateful to the innovators and companies… Read More

FDA Creates New Web-Based Educational Tool About the Agency

Written by Mary Dunkle on February 28, 2014

The Food and Drug Administration’s Office of Orphan Products Development (OOPD), in collaboration with the FDA Center for Drug Evaluation and Research (CDER), has launched a web-based educational tool for rare disease patients, advocacy groups, researchers and industry on various FDA-related topics. Read More

Patients Will Benefit From New Public-Private Partnership

Written by on December 3, 2012

FDA Commissioner Margaret Hamburg, MD, today announced a new public-private partnership to develop regulatory science that will speed patient access to new medical device technologies.  This is the first public-private partnership specifically focusing on this need. (more…)