U.S./EU MRA
Executive Summary
Three-year transition period for the mutual recognition of good manufacturing practices will begin Dec. 7, FDA says in its MRA final rule published in the Nov. 6 Federal Register. FDA said it received 14 comments on the April 10 proposed rule. Some comments "raised significant issues," FDA added, "but none that, in FDA's view, necessitated substantive changes to the proposed rule." The MRA was signed in London on May 18 ("The Pink Sheet" June 22, p. 19)
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