Drug product A is the sponsor’s own product. We included the appropriate metadata along with the necessary documents in Module 3.2.P.
However, drug products B and C are proprietary products of other manufacturers. These two drug products are incorporated into the IND via the right of reference to their respective DMFs.
Should we include the metadata for drug products B and C, even though we won’t be including any related documents in Module 3?
A misstep in the initial sequence of an IND can have far reaching consequences. So, I decided to email CDER‘s eSubmission team and received a response in less than 24 hours. They explained that we should not include metadata for drug products B and C if we are not submitting any documents in the additional 3.2.P sections that would be created. He noted that, “the use of attributes in the 3.2.P section is optional, unlike the ‘S’ section, where attributes are required.”