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2020: The Future of Cutting-Edge Medicines is Now
United States: Regenerative Medicine The U.S. Food and Drug Administration (FDA) is currently reviewing more than 800 investigational new...
Jacquie Mahon
Feb 19, 20208 min read


Subject-Matter Experts and Medical Writers: A Fruitful Alliance
I sighed inwardly as the Chief Medical Officer launched into another long story about the early days of the clinical research...
Jacquie Mahon
Apr 24, 20185 min read


The First of its Kind: An FDA-Approved Drug Label that Promises Delayed Incarceration
It seems many were flummoxed by the recent FDA approval of a label amendment for the established schizophrenia drug Invega Sustenna®. The...
Jacquie Mahon
Mar 2, 20183 min read


Right to Try and the FDA’s Expanded Access Program: No oversight? Or considered compassion.
"We need to fix this. But we do not need to undermine a working program that benefits patients by creating a deeply flawed alternative...
Jacquie Mahon
Feb 21, 20184 min read
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