単語

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Types of IND Applications

•	Commercial IND – submitted by a sponsor that intends to market the product upon FDA approval.
•	Investigator-Initiated IND – submitted by a physician who both initiates and conducts an investigation.
•	Emergency Use IND – issued by the FDA to allow the use of an experimental drug or biologic for the treatment of one patient when there are no other reasonable treatment options and there is not time for submission and review of a regular IND or for IRB review. Research may not be conducted under an emergency use IND. An emergency use IND exemption may be used one time only for a particular drug or biologic at a particular institution. Subsequent uses require prior CHR review and approval. For more information, please review the CHR Guidelines on the Emergency Use and Compassionate Use of Experimental Drugs and Devices.
•	Treatment Use of Investigational Drugs – submitted for experimental drugs showing promise in clinical testing for serious or life-threatening conditions while the final clinical work is conducted and the FDA review takes place. For more information, please seehttp://www.fda.gov/oc/ohrt/irbs/drugsbiologics.html-treatment. CHR review is required for any Treatment IND and Group C Treatment IND studies, even if the FDA has granted a waiver from local IRB requirements.

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製薬企業が
新薬開発（商業目的）の臨床試験の為に提出した
IND（Commercial IND）は１／３。

医師や大学の研究者が
研究目的の臨床試験の為に提出した
IND（Investigator IND）が残りの２／３。