FDA 1571 2006 free printable template

Next Page Export Data Import Data Reset Form DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION Form Approved: OMB No. 0910-0014. Expiration Date: May 31, 2009, See OMB Statement

How to fill out FDA 1571

How to fill out FDA 1571

1. Begin by obtaining the FDA Form 1571, which can be downloaded from the FDA website.
2. Fill out the 'Application Type' section, specifying the type of application you are submitting.
3. Provide details in the 'Sponsor' section, including the name, address, and contact information of the sponsor.
4. In the 'Drug Dosage Form' section, specify the dosage form of the drug being studied.
5. Complete the 'Indications' section, describing the intended use of the drug.
6. Fill in the 'Study Information', detailing the study's design, objectives, and phases.
7. Include any relevant Investigational New Drug (IND) numbers if applicable.
8. Ensure that all required signatures are provided in the designated areas.

Who needs FDA 1571?

1. FDA Form 1571 is required for any sponsors looking to conduct clinical trials for drugs in the United States.
2. It needs to be completed by pharmaceutical companies, academic research institutions, and other entities proposing human clinical trials.

People Also Ask about

What is the purpose of 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 the FDA 1571?

The Form FDA 1571 is used to obtain agreement from a sponsor or sponsor-investigator to conduct research in adherence to all appropriate FDA regulations. It also serves as a cover sheet and is completed for every submission sent to the FDA on behalf of a specific IND.

What is the difference between FDA Form 1571 and 1572?

Form FDA 1571: Coversheet for all IND submissions. The 1571 must be signed by the Sponsor of the IND. Form FDA 1572: Statement of Investigator. The 1572 must be signed by the Principal Investigator of the clinical trial.

What is a 1571 form?

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.

Who completes the 1572 form?

A form that must be filed by an investigator running a clinical trial to study a new drug or agent. The investigator agrees to follow the U.S. Food and Drug Administration (FDA) Code of Federal Regulations for the clinical trial.

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What is FDA 1571?

FDA Form 1571 is a document used to apply for an investigational new drug (IND) status with the FDA.

Who is required to file FDA 1571?

Any sponsor who intends to conduct clinical trials of a new drug or biological product in the United States is required to file FDA 1571.

How to fill out FDA 1571?

To fill out FDA 1571, the applicant must provide detailed information about the investigational drug, the proposed clinical study, and its sponsor, following specific instructions provided by the FDA.

What is the purpose of FDA 1571?

The purpose of FDA 1571 is to notify the FDA of the sponsor's intention to begin clinical testing of an investigational new drug, ensuring oversight and safety.

What information must be reported on FDA 1571?

The information required on FDA 1571 includes the name and address of the sponsor, the names of the drug(s), the proposed usage, the protocols for the study, and any prior investigations related to the drug.