"When a regulatory decision is made, uncertainty can remain about many aspects of a new drug’s performance, said Janet Woodcock, Direc-
tor, Center for Drug Evaluation and Research (CDER), FDA. As a result, she noted, uncertainty is “central to the evaluation of data,” and can affect our understanding of both benefits and risks. Uncertainty in the drug review process has many sources, all of which, she noted, must be analyzed, quantified to the extent possible, judged, and communicated responsibly (see Box 1-3). FDA’s goal is to bring the best possible science to bear on these tasks, in order to ensure that stakeholders and the public have a clear understanding of both the available evidence and the pending uncertainties, and that stakeholders understand that both evidence and uncertainty are important factors in any given regulatory decision"
Page 5: IOM (Institute of Medicine). 2014. Characterizing and communicating uncertainty in the assessment of benefits and risks of pharmaceutical products: Workshop summary. Washington, DC: The National Academies Press