2018-01-03 22:42
(1982 d 16:37 ago)

Posting: # 18137
Views: 1,416

 FDA Draft guidance on Good ANDA Submission Practices [Regulatives / Guidelines]

Hi all,

The FDA just posted a draft guidance on Good ANDA submission practices: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?

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