Launch: Safety Counts

Contributed by:

Robin Robinson

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Approval is no longer the final step,” says Anne Tomalin, president of i3 CanReg. “Companies need to consider the possibility that their product may have to be removed from the market one to two years down the road because a safety signal develops.” In addition to collecting data and managing a difficult registration process, companies must also take into consideration the new Section 905 of the FDAAA that calls for HHS to develop methods to obtain access to disparate data sources and to establish a postmarket risk identification and analysis system to link and analyze healthcare data from multiple sources. The law sets a goal to access data from 25 million patients by July 1, 2010, and 100 million patients by July 1, 2012. The law also requires the FDA to work closely with partners from public… Experts on this topic Anne Tomalin, President of i3 CanReg Nancy Smerkanich, Executive VP, Global Regulatory Affairs, Octagon Research Solutions Ed Damp, Chief Operating Officer, BioPath Consulting Robin Winter-Sperry, M.D., President and CEO of Scientific Advantage and Science Oriented Solutions (SOS)

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