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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
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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
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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
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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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