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news.The FDA has reported that it will expand its post marketing safety activities, and adopt new scientific approaches to drug safety to meet its commitments under the Prescription Drug User Fee Act.
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The agency plans to spend its Prescription Drug User Fee Act (PDUFA IV) fees to fund epidemiology best practices and data acquisition. According to the Drug Safety Five-Year Plan draft, the FDA intends to use the fees to increase the number of employees dedicated to adopting new scientific approaches to drug safety, reducing the risk of medication errors and improving adverse event detection and prevention programs.
In another use of the new PDUFA funds, the FDA plans to develop and implement agency wide and special-purpose postmarket IT systems, including the MedWatch Plus Portal, the FDA Adverse Event Reporting System, the Sentinel System (a virtual national medical product safety system) and the Phonetic and Orthographic Computer Analysis System to find similarities in spelling or sound between proposed proprietary drug names that might increase the risk of confusion and medication errors.
The FDA also plans to hire a contractor to study the various mechanisms for collecting adverse events and determine optimal strategies for collecting adverse event data throughout the product lifecycle.