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eCTD |
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NIST has been working with the Silicon Integration Initiative (Si2), and the RosettaNet consortia to develop the ECTD standard. Submitting fully compliant eCTD submissions requires an understanding of multiple specifications, guidance documents and the agency's 'current thinking'. amp; PARIS -- IDM Pharma (NASDAQ:IDMI) announced today that the company has submitted a Marketing Authorization Application (MAA) in eCTD format (electronic common technical document) to the European Medicines Agency (EMEA) for Mepact (mifamurtide for injection), requesting approval for its use in the treatment of patients with newly diagnosed resectable high-grade osteosarcoma following surgical resection in combination with post-operative multi-agent chemotherapy. |
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