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FDA electronic submission guidance

Executive Summary

FDA publishes guidance on providing regulatory submissions in electronic format addressing pharmaceutical production applications and related submissions in the Federal Register Oct. 19. Guidance outlines filing of NDAs, ANDAs, BLAs, INDs, master files and promotional materials using the electronic Common Technical Document. One in a series of documents, the guidance is intended to facilitate use of the eCTD specifications and provides more specificity than previous guidance documents. The agency is accepting comments...

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