Stakeholders want the US Food and Drug Administration (FDA) to narrow its scope of what it considers labeling in a draft guidance for prescription drug-use-related software (PDURS) frameworks, with many commenters wanting the agency to employ a risk-based approach that considers safety and effectiveness, rather than a broader definition of PDURS and end-user output.
The goal of the draft guidance is to better define how FDA views PDURS, which consists of software that comes from a drug sponsor and creates an outcome related to that sponsor’s product. The draft guidance contains the agency’s proposed thinking on how it would treat PDURS software functions and end-user output as required labeling or promotional labeling. It also elaborates on situations concerning the prescribing information where a drug sponsor either does or does not submits evidence that software is tied to a clinically meaningful benefit, and what software information would need to be included in the prescribing information for a drug product as well as specific considerations for how the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH) would review respective end-user output submitted to the respective centers. (RELATED: FDA releases guidance on labeling of drug use-related software outputs, Regulatory Focus 21 September 2023)…
