USFDA Guidance: Charging for Investigational Drugs Under an IND: Questions and Answers

This draft guidance is released today for Public comments and when finalized, this guidance will replace Charging for Investigational Drugs Under IND — Questions and Answers (June 2016).

This guide provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulations 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.

The revised charging regulation provides the following:

• General criteria for authorizing charging for an investigational drug

• Criteria for charging for an investigational drug in a clinical trial

• Criteria for charging for an investigational drug for an expanded access use under part 312, subpart I

• Criteria for determining what costs can be recovered when charging for an investigational drug

The questions and answers in this guidance are organized as follows:

1. General Questions Related to Charging for Clinical Trials and Expanded Access Use

2. Charging in Clinical Trials

3. Charging for Expanded Access Use

4. Cost Recovery Calculations

Click this LINK to know more about Essential Principles guidance and the Regulatory Guidelines for Medical Devices (ARGMD).