- Docket Number:
- FDA-2022-D-0113
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance describes the FDA’s recommendations regarding clinical pharmacology considerations for conducting human radiolabeled mass balance studies of investigational drugs, including: (1) deciding whether and when to conduct the study, (2) designing the study, and (3) reporting results. This guidance does not cover animal mass balance studies, safety testing of drug metabolites, or recommendations for selecting the radioactive dose.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2022-D-0113.
