Posting: # 18137
The FDA just posted a draft guidance on Good ANDA submission practices:
I found the section on deviations from product-specific guidances to be rather interesting such as:
A detailed justification for and data (such as their inclusion/exclusion criteria or demographic information) to support why their use of a particular study population does not affect their BE determination.
So for imatinib BE studies, which have been done in healthy subjects, but the guidance recommends to use patients, a detailed justification now needs to be provided?