受美国FDA管辖案件确认事项表.DOCVIP

「受美國FDA管轄案件確認事項表」 屬美國FDA管轄之案件，申請時須額外提供之資訊 請勾選符合者： □When research involves the use of a drug other than a marketed drug in the course of medical practice, the drug has an IND or the research meets one of the FDA exemptions from the requirement to have an IND. 研究中使用全球未上市藥品，該試驗用藥須取得FDA核發之IND證明文件， 或者是符合免申請IND No. (請回答問題A) □When research is conducted to determine the safety or effectiveness of a device, the device has an IDE issued by the FDA, the device fulfills the requirements for an abbreviated IDE, or the research meets one of the FDA exemptions from the requirement to have an IDE. 當研究目的是為了確認新醫材的安全性或效能，必須有美國FDA核發之IDE 證明文件，或者是符合免申請IDE. (請回答問題B) 問題A: When research involves the use of a drug other than the use of a marketed drug in the course of medical practice, please confirm that: □The drug has an IND; please provide the IND No.____________ 若勾選此項，請續填並提供所勾選之證明文件： □The number is imprinted on the sponsor’s protocol. □The number is noted in written correspondence from the sponsor. □The number is noted in written correspondence from the FDA (required if the Investigator holds the IND) or □The protocol meets one of the FDA exemptions from the □Exemption 1 ? ˙The drug product is lawfully marketed in the United States. ˙The investigation is not intended to be reported to FDA as a well-controlled study in support of a new indication for use nor intended to be used to support any other significant change in the labeling for the drug. ˙If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is not intended to support a significant change in the advertising for the product. ˙The investigation does not involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product. ˙The investigation is conducted in compliance with 21 CFR 50 and 56.