Analysis: FDA's drug-safety restructure may favor risks
A memorandum of agreement between the Office of New Drugs and the Office of Surveillance and Epidemiology could mean that the Center for Drug Evaluation and Research will favor OSE's perspective on regulatory action for close calls. Some industry experts fear the change may lead to a more cautious, conservative regulatory climate that unfairly weighs the risk side of the risk-benefit equation, according to this RPM Report analysis.
RPM Report, The | 08/2008
This story published in BIO SmartBrief on 08/12/2008
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