[Anonymous]

Reply To: Comparator references in INDs

This question is currently coming up with one study as well. The ex-US regulatory authority classified the comparator as IMP. The comparator will require clinical trial material labeling due to being administered off-label from the marketed indicated regimen. Can a general reference to the comparator be stated in the submission to allow for flexibility of sourcing from more that one manufacturer? With respect to the comparator being classified and labelled as investigational product and its use in the clinical trial is investigational – if additional manipulation of the primary package is performed at the clinical site pharmacy for dose dispensation to multiple subjects is this classified as a primary package operation required to follow cGMP ?