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Electronic Common Technical Document (eCTD) | FDA

    https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd
    Electronic Common Technical Document (eCTD) The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA’s Center for Drug Evaluation and Research...

Electronic Common Technical Document (eCTD) …

    https://www.fda.gov/media/135573/download
    This Electronic Common Technical Document (eCTD) Technical Conformance Guide (Guide) provides specifications, recommendations, and general considerations on how to …

Guideline on the quality requirements for drug …

    https://www.ema.europa.eu/en/documents/scientific-guideline/draft-guideline-quality-requirements-drug-device-combinations-first-version_en.pdf
    45 For the purpose of this guideline, medicinal products which contain one or more medical devices(s) as 46 an integral part of the composition, as well as medicinal products for …

Electronic common technical document | European …

    https://www.ema.europa.eu/en/glossary/electronic-common-technical-document
    Electronic common technical document | European Medicines Agency Electronic common technical document A common technical document in electronic format. Abbreviated as …

Electronic CTD Document Updates to Now Allow …

    https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2013/2/electronic-ctd-document-updates-to-now-allow-information-about-medical-devices,-fda-says
    US Food and Drug Administration (FDA) officials have announced the availability of newly revised final documents that describe the recommended process for …



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