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Author Archives: Kathy Elks

Key Considerations for the Upcoming Mandatory eCTD Requirement

April 27, 2017 | Kathy Elks, Principal Consultant and Jeff Golden, Associate Director | Regulatory Operations

People who work in Regulatory Affairs, and especially those in Regulatory Operations, are well aware of the fact that it is less than a month before eCTD submissions will become mandatory. Starting on May 5th, all NDAs, ANDAs, and BLAs that are submitted to the FDA must be filed in eCTD format.

Many companies have already transitioned to eCTD submissions. However, for those companies that have not transitioned to eCTD submissions, we have some things to keep in mind regarding the requirement.

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Recent Requirement to File Post-Marketing Periodic Safety Reports in eCTD Format

January 14, 2016 | Kathy Elks, RAC, Director, Regulatory Operations | Regulatory Operations

Did you know that there are some areas within our industry where electronic common technical document (eCTD) format is already mandatory? If not, read on.

In a previous blog, I discussed FDA guidance from May 2015 which set the “wheels in motion” for mandatory eCTD submissions. Starting in May 2017, all marketing applications to the FDA (ie, NDAs, ANDAs, BLAs, and DMFs) must be submitted in eCTD format. All INDs and IND amendments must be in eCTD format beginning in May of 2018. Waivers and exemptions to this requirement were discussed in the previous blog.

As of September 2015, some documents are already required in eCTD format. Let me explain.

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Finally, the Deadline for Mandatory eCTD Submissions

May 19, 2015 | Kathy Elks, RAC, Associate Director, Regulatory Operations | Regulatory Operations

In a previous post, the timeline for mandatory electronic submissions to the FDA was discussed. Within that post, we introduced the “mother” guidance, published in December 2014, which explained that it wasn’t feasible for FDA to describe and implement the electronic format of all submission types within a single guidance document.

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Ready, Set, Submit … Electronically

February 26, 2015 | Kathy Elks, RAC, Associate Director, Regulatory Operations | Regulatory Operations

Our clients often ask when the FDA will require all regulatory submissions to be submitted electronically, in eCTD format. And now we have an answer. Sort of.

FDA recently finalized a guidance document that sets the stage for this upcoming requirement.

changeBackground
The FDA Safety and Innovations Act (FDASIA) of 2012 amended the FD&C Act by adding Section 745A, which addresses electronic submissions. The law states that certain NDA, ANDA, BLA, and IND submissions must be submitted to the FDA in electronic format, according to a timeframe to be determined by the FDA.

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