FDA’s New Population Pharmacokinetics Guidance  What Drug/Biologic/Device Makers Need to Know

FDA recently published its new “Population Pharmacokinetics Guidance for Industry” to help set the safety and efficacy of pharmaceutical products. Guidance signals an increased focus on the effects of drug dosing for subpopulations based on sex, age, body, weight, and other factors and asks for applicable drugs to be studied on pediatric patients.

For some medical device companies and digital health companies, the increased parsing out of pharmacokinetics (PK) in these subpopulations may impact the design assumptions for algorithms used in companion diagnostics and drug-dosing calculators. These types of devices tend to have incorporated a specific PK from the drug labeling, usually deep within the product design and often hard coded. If the pharma company modifies or adds PK information to the drug label, then the device manufacturer will need to update their device design to match that. These types of updates often require a new premarket submission to FDA prior to placing the updated device on the market. 


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