The US Food and Drug Administration (FDA) has finalized a guidance that lays out clinical pharmacology information that sponsors of investigational drugs conducting human radiolabeled mass balance studies should include in their premarket applications. While the agency made some changes based on industry feedback, the final guidance is mostly unchanged from the draft version.
On 18 July, FDA finalized the guidance, which was initially published in draft form in May 2022. It lays out when sponsors should consider conducting radiolabeled mass balance studies, how they should be designed, and how to report the results. (RELATED: FDA sheds light on conducting human radiolabeled mass balance studies, Regulatory Focus 10 May 2022)…
