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FDA Draft guidance on Good ANDA Submission Practices [Regulatives / Guidelines]

posted by BRB - Canada, 2018-01-03 21:42  - Posting: # 18137
Views: 852

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The FDA just posted a draft guidance on Good ANDA submission practices: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

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