Risk Analyses have always seemed to me to be subjective in many cases. In this draft guidance, the FDA is looking at how context of use - related risk analysis of a variety of inputs on the "human factor" in taking/administering prescription and nonprescription medications can be included in determining the overall safety of the product during the approval process. A simple way to look at this is what risks exist for use errors putting the patient or others at risk and what has been done to mitigate those risks.
This draft guidance points to two other final and two draft guidance for more insights on conducting 'human factor' studies.
#fda #HumanFactor #Risk #DraftGuidance
https://www.fda.gov/media/179858/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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