Risk and the Economics of Regulatory Compliance | PDA Journal of Pharmaceutical Science
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The Regulation of Pharmaceuticals: Balancing the Benefits and Risks | Policy Commons Skip
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The 'cautious regulator'problem has been named as one of the four main causes of
increasing R&D costs and declining R&D efficiency [3]. Often, the regulatory ratchet is …

Analyses of risk management within prescription pharmaceutical regulation are rare. We
present the first comparison of pharmaceutical risk regulation between the EU's centralised …

This paper addresses the role of uncertainty in challenges confronting the US
pharmaceutical industry and its regulators. It begins with a macroeconomic overview …

The pharmaceutical industry is of interest to the field of law and economics for three related
reasons that modify the application of the standard analysis of structure, conduct and …

Failure to adequately address the issue of risk/benefit assessment during drug development
can result in delays in the approval of new drugs. The concept of risk/benefit is elusive to …

There is plenty of controversy surrounding pharmaceuticals, but it cannot be denied that the
pharmaceutical industry is both socially beneficial and profitable. Regulators are expected to …

This book guides the reader through FDA regulation guidelines and outlines a
comprehensive strategy for cost reduction in regulatory affairs and compliance. This book …

Patients taking prescription drugs, as the chapters of this volume show, are at risk for
adverse drug reactions, overtreatment, unsuitable treatment, disease mongering, and …