FDA Charging for Investigational Drugs Under an IND - Questions and Answers Guidance for Industry

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Charging for Investigational Drugs Under an IND - Questions and Answers Guidance for Industry[附网盘链接]是FDA于之前发布的FDA标准，适用于美国。

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Charging for Investigational Drugs Under an IND — Questions and Answers 1

Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. INTRODUCTION This guidance provides information for industry, researchers, physicians, institutional review boards (IRBs), and patients about the implementation of FDA’s regulation on charging for 2

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 3

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 4

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 5

expanded access requests for individual patient INDs. 1

This guidance has been prepared by the Office of Medical Policy in the Center for Drug Evaluation and Research in cooperation with the Center for Biologics Evaluation and Research at the Food and Drug Administration. 2

For the purposes of this guidance, the terms investigational new drug, investigational drug, drug, and drug product refer to both human drugs and biological products regulated by the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research. 3

Federal Register of August 13, 2009 (74 FR 40872). 4

See the guidance for industry Expanded Access to Investigational Drugs for Treatment Use – Questions and Answers for the Agency’s current thinking on this topic. We update guidance documents periodically. To make sure you have the most recent version of a guidance, check the FDA guidance Web page at http://www.fda.gov/RegulatoryInformation/Guidances/. 5

See the guidance for industry Individual Patient Expanded Access Applications: Form FDA 3926 for the Agency’s current thinking on this topic.

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