Document to Support Submission of an Electronic Common Technical Document – Specifications for File Format Types Using eCTD Specifications; Availability

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Docket ID : FDA-2013-N-0385
Agency : Food and Drug Administration (FDA)
Parent Agency : Department of Health and Human Services (HHS)
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Related RINs: None
Related Dockets: None
Docket Item Code: N
Type: Nonrulemaking
Center: CDER
Keyword(s): cder, cder201315, Technical Document , Common Technical Document, eCTD, Specifications for File Format, Harmonisation, ICH, Modules 2 , labeling, International Conference on Harmonisation
Docket Status: OPEN
 
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