Jacquie MahonFeb 19, 20208 min2020: 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 MahonApr 24, 20185 minSubject-Matter Experts and Medical Writers: A Fruitful AllianceI sighed inwardly as the Chief Medical Officer launched into another long story about the early days of the clinical research...
Jacquie MahonMar 2, 20183 minThe First of its Kind: An FDA-Approved Drug Label that Promises Delayed IncarcerationIt seems many were flummoxed by the recent FDA approval of a label amendment for the established schizophrenia drug Invega Sustenna®. The...
Jacquie MahonFeb 21, 20184 minRight 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...