FDA New Module 1 Implementation Delayed Until Q2 2014

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The new US eCTD Module 1 first appeared on the Federal Register (FR) docket in October 2011. After the required comment period, a final version appeared in 2012 and a public meeting was held. Currently, the stated timeline to accept submissions containing the new Module 1 is September 2013. While the FDA has made significant progress on Module 1, we anticipate the announcement of a revised timeline later this summer.

Why
is this process taking longer than expected, and when will the FDA actually implement the new Module 1 specifications?
As CDER and CBER’s promotional department are new to electronic submission and the eCTD review, the industry should expect some changes to the specification and requirements for these submissions. The most recent change to Module 1 was posted in April, illustrating this point; as additional attributes were added to the specification for clarification.
The good news is that this project remains a high priority at the FDA. Taking that into consideration, a likely scenario would be for the FDA to implement during Q2 2014. In any scenario, the FDA promises to provide notice at least 30 days in advance of implementing new software.
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Author: Rahul Mistry

Rahul Mistry is a veteran of the software industry. Mr. Mistry has two decades experience working in the technology product and services field. He was instrumental in the development of the eCTD REVIEW™ and VALIDATE™ software now used exclusively by the U.S. Food & Drug Administration to assess the technical integrity of each drug application the FDA receives.

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