This draft guidance is not long – only 11 pages- but in my preliminary read through a few things stood out.
The Agency is focusing on early interactions with sponsor on specific topics: "We anticipate that early engagement will focus on indication-, disease-, organ-, and endpoint-specific considerations that should include interactions with review divisions.".
The guidance is focused on validation of the NAMs and clearly differentiates 'validation' from 'qualification': "Validation is a process by which the accuracy, reliability, and relevance of a procedure are established for a specific context of use (COU). Qualification is a determination that a drug development tool and its proposed COU can be relied upon to have a specific interpretation and application in drug development and regulatory review.". This highlights to me that assays should no longer be referred to as 'qualified' when the intent is less than fully validated.
The Agency goes into details on the four key features of any validation approach they are expecting: "(1) COU, (2) human biological relevance, (3) technical characterization, and (4) fit-for-purpose".
And if you were wondering if the guidance was going to point to the Bioanalytical Method Validation guidance, it doesn't. It points to the OECD Guidance Document on Good In Vitro Method Practices (GIVIMP) as a key reference for validations but provides additional framing and expectations.
#fda #NAM
https://www.fda.gov/media/191589/download
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Mark Arnold Ph.D., FAAPS
Westampton, NJ
[email protected]Bioanalytical Solution Integration
LinkedIn:
https://www.linkedin.com/in/markearnoldphd/Website & Blog: Bioanalysis & Biomarkers <bioanalysisandbiomarkers.blogspot.com>
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