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FDA Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers

蒋千琴 4/12/2022 浏览 742 FDA U.S

标准简介

Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers[附网盘链接]是Food&Drug Administration于不久前发布的FDA标准，适用于U.S。

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Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers[附网盘链接]
Expanded Access to Investigational Drugs for Treatment Use - Questions and Answers[附网盘链接](截图)

 

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标准部分原文

Contains Nonbinding Recommendations Expanded Access to Investigational Drugs for Treatment Use — 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 office 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 regulations on expanded access 2 to investigational drugs for treatment use under an investigational new drug application (IND) 3 (21 CFR part 312, subpart I), which went into effect on October 13, 2009. Since 2009, FDA has received a number of questions concerning implementation of the regulations. As a result, FDA is providing guidance in a question and answer format, addressing the most frequently 4 asked questions. In a separate guidance, FDA provides answers to questions concerning the implementation of the regulation on charging for investigational drugs under an IND (21 CFR 5 312.8). Also in a separate guidance, FDA describes Form FDA 3926 (Individual Patient Expanded Access—Investigational New Drug Application (IND)) and the process for submitting 6

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 drug 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 40900). 4

See the guidance for industry Charging for Investigational Drugs under an IND—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 https://www.fda.gov/RegulatoryInformation/Guidances/. 5

See also 74 FR 40872, August 13, 2009. 6

See the guidance for industry Individual Patient Expanded Access Applications: Form FDA 3926.

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