This guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulation on charging for investigational drugs under an investigational new drug application (IND) for the purpose of either clinical trials or expanded access for treatment use (21 CFR 312.8), which went into effect on October 13, 2009. Since 2009, FDA has received a number of questions concerning its implementation of the charging regulation. As a result, FDA is providing guidance in a question and answer format, addressing the most frequently asked questions. In a separate guidance, FDA provides answers to questions concerning regulations on expanded access to investigational drugs for treatment use (21 CFR part 312, subpart I), which also went into effect on October 13, 2009. Also in a separate guidance, FDA describes Form FDA 3926 (Individual Patient Expanded Access--Investigational New Drug Application (IND)) and the process for submitting expanded access requests for individual patient INDs.
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.