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Drug Master File Submissions To Be In Electronic Common Technical Document (eCTD) Format.pdf

ucm535734.pdf
Preview of drug master file submissions to be in Electronic Common Technical Document (eCTD) format
🔗 Source: fda.gov
📊 Size: 98 KB
👤 Author: U.S. Food and Drug Administration
⬇️ Downloads: 245

Summary

As of May 5, 2018, all Master File (MF) submissions must be in Electronic Common Technical Document (eCTD) format. Tips for getting started include using the same MF application number when converting from paper to eCTD, and noting that eCTD format requires a 6-digit application number. Submissions of 10 GB or less must use the Electronic Submission Gateway (ESG), and an ESG account should be obtained early. Cover letters should provide a clear description of the submission, include the U.S. agent's information, and provide a point of contact for technical issues. Documents should follow FDA PDF specifications, and bookmarks, tables of contents, and hyperlinks should be provided for documents of five pages or longer. When submitting, request an application number from CBER or CDER, and choose the correct center and submission type. Additional resources are available on the FDA website.

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Description

As of May 5, 2018, all Master File (MF) submissions must be in Electronic Common Technical Document (eCTD) format.

Technical Information

  • File Format: PDF
  • File Size: 98 KB
  • Pages: 2
  • Language: EN
  • Author: U.S. Food and Drug Administration
  • Total Downloads: 245
  • Last Updated: 3 weeks ago

Document Overview

This PDF document about drug master file submissions to be in Electronic Common Technical Document (eCTD) format provides comprehensive information and guidance. Whether you're a beginner or advanced user, this resource offers valuable insights into drug master file submissions to be in Electronic Common Technical Document (eCTD) format.

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