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Guidance for Industry and Food and Drug Administration Staff - User Fees and Refunds for Premarket Approval Applications and Dev

Posted Apr 01 2013 12:00am
During the review of a premarket submission, the review clock is impacted by both FDA?s and Industry?s action. The Medical Device User Fee Amendments of 20121 (MDUFA III), amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) to authorize FDA to...
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