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# Draft Guide on Charging for Investigational Drugs
- URL: https://www.fdaweb.com/draft-guide-on-charging-for-investigational-drugs/
- Published: 2022-08-22T12:00:00.000Z
- Updated: 2026-09-14T17:56:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152561

FDA has issued a revised draft guidance entitled “[Charging for Investigational Drugs Under an IND: Questions and Answers](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDEsInVyaSI6ImJwMjpjbGljayIsImJ1bGxldGluX2lkIjoiMjAyMjA4MjIuNjI2MTExMjEiLCJ1cmwiOiJodHRwczovL3d3dy5mZGEuZ292L3JlZ3VsYXRvcnktaW5mb3JtYXRpb24vc2VhcmNoLWZkYS1ndWlkYW5jZS1kb2N1bWVudHMvY2hhcmdpbmctaW52ZXN0aWdhdGlvbmFsLWRydWdzLXVuZGVyLWluZC1xdWVzdGlvbnMtYW5kLWFuc3dlcnMtMD91dG1fbWVkaXVtPWVtYWlsJnV0bV9zb3VyY2U9Z292ZGVsaXZlcnkifQ.hMbEO-E%5Fi85kWyptmROlYuP3rtgjxJPof7PBqZEIhaI/s/1255931999/br/142908678341-l?ref=fdaweb.com).” The document answers frequently asked questions on FDA’s processes, policies and regulations about drug companies charging patients for investigational new drugs under certain circumstances in clinical trials or when expanded access is granted.

The agency says that since 2009 when its regulations on charging for investigational drugs went into effect, it has received questions from stakeholders related to implementing the charging process. When finalized, the guidance will replace the 2016 final guidance under the same title. Significant changes to the 2016 version include additional recommendations related to the need for submitting a statement by an independent certified public accountant under certain circumstances, and distribution of the manufacturing, administrative, or monitoring costs from the first year over the expected duration of the expanded access IND or protocol.