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Regulatory and Clinical Requirements for Prescription to OTC Switches in USA and India
- By: Mithun Raja. B, Raghavendra Rao. K
- Date: May 28, 2013
Abstract:In this article, Mithun Raja B. and Raghavendra Rao K., explain the clinical and regulatory requirements governing the process of prescription to OTC switches in USA and India. The article discusses the reasons for these switches, the process itself and what regulatory agencies in both countries require from pharmaceutical manufacturers.
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