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Under the latest reauthorization of MDUFA, the agency only committed to providing complete performance reports on organizations with at least five 510(k) submissions. Read More
The approval was based on two clinical studies with statistically significant reductions in treated bleeds compared to previous treatments with a bypassing agent. Read More
The stay will be either until March 30, until the guidance’s early publication, or an announcement that the guidance will be published after March. Read More
When future new study data standards are listed in the Catalog, the new standards will be required in studies with a start date no earlier than 12 months after a Federal Register notice. Read More