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Regulatory News In Brief

This article was originally published in The Gray Sheet

Executive Summary

Devices for rare diseases: 1AdvaMed and 2Medtronic say FDA device reviewers should take a page from the agency's orphan drugs program and allow makers of approved humanitarian-use devices to gain market exclusivity for a time, make a profit on the devices and obtain tax credits similar to those for orphan drugs. FDA should also be able to tailor the maximum patient population size for a humanitarian-use device, the groups said in Aug. 31 comments on regulation of products for rare diseases. Currently, humanitarian-use devices must be designed for conditions that affect fewer than 4,000 patients per year. Regulators should be allowed "to selectivity raise the cap for specific conditions when FDA determines the health of orphan or pediatric patients requires an increase ... based on medical, demographic and scientific information provided by a petitioner," AdvaMed writes. In June, FDA held a workshop on regulation of products to treat rare diseases (3"The Gray Sheet" July 5, 2010)

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