Electronic Common Technical Document definition

Electronic Common Technical Document. (eCTD) means the standard format for electronic regulatory submissions as described in the most recent final revision to FDA Guidance for Industry entitled “Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the Electronic Common Technical Document Specifications.”
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Examples of Electronic Common Technical Document in a sentence

  • If applicable, the Awardee shall prepare an IND/BLA in the Electronic Common Technical Document (eCTD) format for submission to the FDA and the Government.

  • If applicable, Redhill shall prepare an IND/BLA in the Electronic Common Technical Document (eCTD) format for submission to the FDA and the Government.

  • Phone: 2▇▇.▇▇▇.▇▇▇▇ Fax : 8▇▇.▇▇▇.▇▇▇▇ Email : e▇▇▇▇.▇▇▇▇▇@▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇ The electronic submission is in the Electronic Common Technical Document format (eCTD) and sent via the FDA Gateway; sequence 0000.

  • If applicable, the Awardee shall prepare an IND application in the Electronic Common Technical Document (eCTD) format for submission to the FDA and the Government.