What is the FDA form 1571?
What is the FDA form 1571?
The FDA Form 1571 or ‘1571’ is the IND application cover page and it must accompany the initial IND submission and any amendments, IND safety reports, annual reports or general correspondence the sponsor submits to the FDA about the IND. The 1571 is a contractual agreement between the sponsor and the FDA.
What is the purpose of FDA Form 1571?
What is the FDA 1571 form? Form FDA 1571 is used for two purposes: 1) to obtain agreement from the sponsor (or sponsor-investigator) to conduct research according to all appropriate FDA regulations; and 2) to serve as a cover sheet for all submissions to the FDA on behalf of a particular IND.
How do I fill out an IND?
The IND should include the following information:
- Statement that this is a request for an individual patient IND for treatment use. You will need to specify whether it is an emergency IND or individual patient IND.
- Provide a brief clinical history of the patient including:
- Indicate the proposed treatment plan including:
What is the investigational new drug application form called?
Form FDA 1571
An Investigational New Drug Application (IND) is a request for Food and Drug Administration (FDA) authorization to administer an investigational drug to humans.
Do 1572s expire?
No. There is no need to prepare and sign a new 1572 when the OMB expiration date has been reached.
What is an IND serial number?
IND submissions should be consecutively numbered. The initial IND should be numbered “Serial Number: 0000.” The next submission (e.g., amendment, report, or correspondence) should be numbered “Serial Number: 0001.” Submissions should be numbered consecutively in the order in which they are submitted.
When Should 1572 be submitted?
When Must the Form be Updated or a New One Completed? In cases when a new site is added or of replacement of an investigator at an existing site, a 1572 must be submitted to the FDA within a 30-day window of the site’s/investigator’s addition/replacement.
Who has ultimate responsibility for an investigational device at the site?
investigator/institution
Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution. The Investigator is responsible to ensure control of investigational product.
How much does it cost to file an IND?
FY 2014 – FY 2017
| Submission Type | FY 14 | FY 15 |
|---|---|---|
| Drug Applications | ||
| IND | $459.0 | $550.3 |
| NDA Clinical Data – NME | $5,646.4 | $5,250.5 |
| NDA with Clinical Data – Non-NME | $1,845.2 | $1,356.2 |
Who must be added to 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.
Under which circumstances does the FDA allow verbal consent?
FDA calls for researchers as parts of ethical requirements to seek consent before the research. Verbal consent is considered if the research does not pose significant risk.