m Meiyi
on

 

We need to submit ISS for NDA. When we reviewed the ADaMs for ISS, we found out that IADSL has multiple record per subject and IADAE has multiple records for the same AE event on the same date for the subject. We have the following questions for you:

 

For ISS ADSL:

      Will FDA accept or reject when we name it as IADSL instead of ADSL?

      Will FDA accept or reject when ADSL or IADSL has multiple records for one subject? (Our current ISS  IADSL  structure is one record per subject per pool).

 

For ISS  ADAE:

      Will FDA accept or reject when we name it as IADAE instead of ADAE?

      Will FDA accept or reject when ADAE or IADAE has multiple records for the same AE starting on the same day for one subject?

Forums: ADaM

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