Under 21 CFR 312.8, who requests authorization from FDA to charge for an investigational drug for use under an IND?

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Section 312.8 permits only the sponsor of the IND to request FDA’s authorization to charge for an investigational drug for use under the IND. The sponsor of the IND is not always the manufacturer of the drug.

For example, if the manufacturer of an unapproved drug is not the sponsor of the IND under which the drug will be used, the manufacturer is not required to obtain authorization from FDA to charge the sponsor of the IND for the unapproved drug. However, in such a situation, if the sponsor wants to charge patients to recover the cost charged by the manufacturer, the sponsor must obtain FDA’s written authorization before it can begin charging patients.

About the Author
Proxima CRO Team
Ellie Reynolds
Quality Assurance

Ellie Reynolds is from Dallas, Texas and is a Quality Assurance and Regulatory Affairs Associate for Proxima. She just completed her M.B.E. in Bioengineering at Rice University and previously received her B.E. in Biomedical Engineering from Vanderbilt University. Prior to completing her master's degree, she worked in strategy consulting for biotech and pharma companies and is eager to combine her educational background and professional experience in this role.  

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