On Thursday, June 2nd the FDA issued a final guidance, entitled “Charging for Investigational Drugs Under an IND — Questions and Answers.” The guidance provides information concerning the implementation of the Agency’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).”
Title 21 of the Code of Federal Regulation Section 312.8 took effect in October 2009, replacing the FDA’s 1987 rule that authorized the Agency to charge for an investigational drug. The revisions that were made in 2009 include:
Since 2009, the FDA has received numerous questions regarding the implementation of its charging regulation. These inquiries are the driving force behind FDA’s recent guidance document, which “guidance in a question and answer format, addressing the most frequently asked questions.”
In the recent final guidance, FDA organized the questions and their respective answers into four distinct categories, including:
Among these questions, the FDA includes information concerning the time frame for reviewing and responding to a request, as well as details regarding who requests authorization and is charged by the sponsor. In this subsection of questions, the following information is provided:
The guidance document touches on various topics involving clinical trials, providing the following information:
In addition to the information listed above, FDA provides answers to a number of additional questions that it receives frequently. For more on these questions and answers, view the full guidance document.
With regard to charging for expanded access use, the Agency provides the following:
The final category of questions included in the guidance document addresses topics relating to cost recovery, including the following:
The Agency provides additional details on the information that a sponsor must submit to FDA in support of its cost calculation(s). To learn more, view the FDA’s full guidance document.
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