New FDA M1 Specifications include DDMAC, Bundled Submissions

As reported last month, the two significant changes to the specifications are is inclusion of DDMAC submission and bundled submissions. The largest change to FDA’s regional DTD is now one sequence can be submitted to multiple applications. This is a great feature if you create a single submission and replicate it to send to multiple applications. The only drawback to this plan is once you submit a bundled submission, the lifecycle for the document submitted cannot diverge in any of the applications.

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