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When submitting your form FDA 1571 investigational new drug application what components are required?

Filing an IND requires completion of 3 sets of forms: 1 detailing the study (FDA Form 1571), 1 providing information about the investigator and study site (FDA Form 1572), and 1 docHubing that the study is registered in the national database of clinical trials (FDA Form 3674).

What is Form 3542?

Form FDA 3542 Used to submit patent information on a patent that. claims the following: An approved drug. An approved method of using the drug. Submitted upon approval of an NDA or supplement.

What is FDA Form 3542?

Use this Form FDA 3542a only if the NDA applicant is submitting information on a patent that claims a proposed drug or a proposed method of using the drug that is the subject of the pending NDA, an amendment, or a supplement.

Who needs to be on the 1572?

A new 1572 is required when an investigator is participating in a new protocol that is added to an active IND and when the Principal Investigator of an ongoing study changes, when a Sub-Investigator is added, and when there is a change of location in which the study is being conducted.

What is a FDA Form 1571?

Purpose. An Investigational New Drug Application (IND) is a request for Food and Drug Administration (FDA) authorization to administer an investigational drug to humans.

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