Bioequivalence and Bioavailability Forum • FDA Draft guidance on Good ANDA Submission Practices

BRB
☆

Canada,
2018-01-03 22:42
(2297 d 18:53 ago)

Posting: # 18137
Views: 1,538

FDA Draft guidance on Good ANDA Submission Practices [Regulatives / Guidelines]

Hi all,

The FDA just posted a draft guidance on Good ANDA submission practices:

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM591134.pdf

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?

BRB