Rules for Submitting Electronic DMFs to FDA, Health Canada
Jan14

Rules for Submitting Electronic DMFs to FDA, Health Canada

The U.S. FDA and Health Canada have each updated their submission requirements for Drug Master Files (DMFs). Understanding each agency’s requirements will be critical to compliance in the coming months as eCTD mandates go into effect.

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Five Points to Consider When Selecting an Enterprise eCTD Viewer
Oct16

Five Points to Consider When Selecting an Enterprise eCTD Viewer

When selecting a system for cross-department viewing of eCTD submissions, as well as archiving, here are some important points you’ll want to give proper attention.

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The End of Paper Submissions
May11

The End of Paper Submissions

The release of the final binding guidance now sets in motion a 24-month timeline. Using the May 5th date as a guide, it stands to reason that submission types NDA, ANDA, BLA, and master files must be submitted in eCTD format beginning May 5, 2017. IND submissions would be required May 5, 2018.

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GlobalSubmit Presents eCTD Essentials in Multiple Cities this October

In recent years eCTD has become the preferred format for regulatory submissions worldwide, and momentum continues to build as mandates take effect in Europe and the United States. Compiling an electronic regulatory submission is a challenging task even for industry veterans who’e worked on multiple projects. Naturally, an organization making the transition from paper to electronic format or compiling a submission for the first...

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FDA Online Instruction for eCTD Submissions

The CDER Small Business Assistance Program recently posted a web-based training course on electronic submission in eCTD format. The primary goal and purpose of CDER’s training is to encourage sponsors to submit in eCTD format. The training explains the FDA’s policies and practices regarding electronic submissions and provides sponsors with the fundamental information needed to submit new and transition old applications to...

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