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Hello everyone,
The Module 3 of our IND (in eCDT format) has several historical drug substance (and product) lots that have been tested by different analytical methods to different specifications. We are now drafting a CMC amendment to report an update to the analytical method that could be applied to any of the lots, and will definitely be used for lots going forward. In this CMC amendment, would you:
1) "Overwrite" the previous detailed Analytical Method description and Analytical Method Validation sections (replace old method information with new), since the previous versions of the IND have detailed the old method.
or
2) Just add the new information and retain the old, since the old method was used to test the old lots, which we still use for decision-making.
I'm just hoping to report in a way that makes the history clear to the FDA reviewers.
Thanks very much for your recommendations!