U.S./EU MRA
This article was originally published in The Gray Sheet
Executive Summary
FDA go-ahead for three additional EU CABs is anticipated in the next month, the agency indicates. Final confirmation will allow the CABs to perform select independent premarket reviews and quality systems inspections under the U.S./EU mutual recognition agreement. In January, the UK's SGS Yarsley became the first CAB to gain FDA confirmation. The confidence-building phase of the MRA, likely to be extended by two years, is expected to be among topics discussed at an upcoming March 14 MRA stakeholder teleconference. The MRA confidence building phase was originally slated to end in December 2001(1"The Gray Sheet" Nov. 26, 2001, p. 13)...