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“I think it is really important for the public and the patient Community to learn a little more about FDA advisory committees because these are public meetings and they're accessible for anyone to attend and learn from.” Mary Rofael, MD
An FDA Advisory Committee is one of the biggest moments in the development of a new treatment. As a drug developer, I consider the FDA Ad Comm as the pinnacle of my career. During these hearings, a company is given a short time to make the case for the approval of their New Drug Application (NDA) and answer questions from a panel of independent experts. The FDA has a similar opportunity to present their concerns and question to that panel of experts. And all this is done in public.
Needless to say, consolidating 12-15 years of collected data into a couple of hours is daunting. Over the past 20+ years, Mary Rofael, MD has built a business, ProEd Communications, that helps guide companies through this major event. In this episode were learn how those companies prepare, what ProEd Communications brings to the table, and why Mary finds this work so fulfilling.
Contact Mary Rofael: mrofael@hcg-int.com mnrofael@gmail.com https://proedcom.com/
Sound Design Jacob Tompkins (losstudiosnc@gmail.com)
Music “Origins” Per Kilstofte https://machinimasound.com/
“AS – Tribal O1” Aaron Spencer https://machinimasound.com/
Graphic Design Heather McCullen (heathermccullen@salemoaks.com)
