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I am stepping into a regulatory function, and have started by helping prepare the CMC section of submissions for a small molecule investigational drug product.  Does anyone have experience with the CMC section of an IMPD?  I am specifically trying to figure out the following:

1.  I do not see a requirement for annual reports for IMPDs.  Is this correct?   I understand that an amendment to the IMPD is required if a "substantial" change is proposed.  However, if there are not annual reports, I am struggling to understand if and when the kind of information included in IND annual reports (stability data) would be reported for an IMPD.

2. We are currently working on an amendment.  What and how (or should?) should information regarding "Batch Analyses" be provided?  Our previous IMPD amendment included the certificates of testing for all new lots, but I am wondering if a table summarizing those test results is sufficient.  

3. I am also wondering if the "Batch Analyses" sections should be inclusive (all batches created and used in clinical studies since the beginning of the trial) or only summarize the batches used in the trial that have not yet been reported in another submission.

I'd love to hear any experiences you've had or about any guidance document I'm overlooking to help answer these questions!  Thank you!