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Guidance on Electronic Submissions with eCTD Specs

10/19/2005

Federal Register Notice: FDA is making available a guidance for industry entitled Providing Regulatory Submissions in Electronic Format — Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications. One of a series, this guidance discusses issues related to the electronic submission of NDAs, ANDAs, BLAs, INDs, master files, advertising material, and promotional labeling using the International Conference on Harmonization electronic common technical document (eCTD) specifications. To download this guidance, click here. To view this notice, click here.

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