Author: [AUTHOR] Published on 10/4/2024 12:00:00 AM
Available Now: Guidance Snapshot & Podcast for FDA Guidance on Clinical Pharmacology Considerations For Human Radiolabeled Mass Balance Studies
In July 2024, the US Food and Drug Administration (FDA) published the final guidance for industry Clinical Pharmacology Considerations for Human Radiolabeled Mass Balance Studies. This guidance provides the FDA’s recommendations on clinical pharmacology considerations for conducting human radiolabeled mass balance studies of investigational drugs, including: (1) whether and when to do the study, (2) designing the study, and (3) reporting results.
The FDA recently published the following communication materials for the guidance document: Guidance Snapshot, audio Guidance Recap Podcast, and podcast transcript. The Guidance Snapshot includes the following categories of information:
- Key recommendations from the guidance document
- Considerations for designing mass balance studies
- Reporting of human radiolabeled mass balance study results
- Drug development timeline for when to apply the guidance recommendations
- Links to the guidance document, podcast, and other related resources
The Guidance Snapshot and Guidance Recap Podcast are part of the FDA’s Guidance Snapshot Pilot Program that aims to increase the general public’s awareness of and engagement with FDA guidance documents—and support the application of the recommendations in the guidance documents. The snapshots and podcasts that accompany guidance documents are not substitutes for the guidance documents; rather, they support the transparent communication and dissemination of FDA guidance documents. The snapshot uses visuals and plain language to highlight the key points in the guidance document. The podcast is an interview with the guidance document’s authors who discuss the background, intent, and other key recommendations of the guidance document. Visit the FDA’s Guidance Snapshot Pilot Program’s web page to learn more about the Pilot Program, read guidance snapshots, and to listen to the podcasts.
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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
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