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MRA three-year confidence building period will be "entirely open process" -- FDA's Gray.

This article was originally published in The Tan Sheet

Executive Summary

MRA CONFIDENCE BUILDING PERIOD WILL BE "ENTIRELY OPEN," FDA says, as it pertains to the agency's determinations of regulatory equivalence during the implementation of the U.S./European Union mutual recognition agreement, Office of Compliance Director Stephanie Gray told the Drug Information Association annual meeting in Boston June 8-11. FDA plans "to provide for additional opportunities to follow and comment on the implementation of the MRA," Gray said. "We think it is very important to have an entirely open process so that people understand why decisions were made."
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