USA – FDA finalizes guidance on charging for investigational drugs

The US Food and Drug Administration (FDA) on 14 February finalized guidance specifying the circumstances when sponsors can charge for an investigational drug in a clinical trial or for expanded access use.

The regulation under 21 CFR 312.8, which took effect in October 2009, allows sponsors in certain circumstances, to charge patients for investigational drugs under an investigational new drug application (IND) or for receiving expanded access treatment. The guidance, which is in a question-and-answer format, is aimed at industry, researchers, physicians, institutional review boards and patients.

The document replaces the revised draft guidance issued in August 2022, and replaces the final guidance issued in June 2016 (RELATED: FDA allows sponsors to spread out costs in revised IND charging guidance, Regulatory Focus 23 August 2022)…