Form 3674 pdf-2025

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The document is a certification form (FDA 3674) required by the Food and Drug Administration (FDA) for compliance with the ClinicalTrials.gov Data Bank under 42 U.S.C. § 282(j). It must accompany applications or submissions related to drugs, biologics, or devices, confirming whether clinical trial requirements apply. The form includes sections for sponsor information, product details, application type, and certification statements regarding clinical trials referenced in the submission.

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What is the purpose of the FDA Form 1572?

Registration and listing provides the FDA with the location of medical device establishments and the devices manufactured at those establishments. Knowing where devices are made increases the nations ability to prepare for and respond to public health emergencies.

Do you have to submit a clinical study report to the FDA?

Federal law requires responsible parties to register with and submit results information to the ClinicalTrials.gov data bank for certain applicable clinical trials.

What is the purpose of FDA form?

The Form FDA 483 notifies the companys management of observed objectionable conditions. At the conclusion of an inspection, the Form FDA 483 is presented and discussed with the companys senior management.

What is the difference between the FDA form 3455 and 3454?

Certification, using Form FDA 3454, that either no financial interests or arrangements exist or that the applicant acted with due diligence but was unable to obtain the information; Disclosure, using Form FDA 3455, of the nature of disclosable financial interests and/or arrangements; or Both certification and

What is a 3674 form?

Form 3674 must accompany an application/submission, including certain amendments, supplements, and resubmissions, submitted under 505, 515, 520(m), or 510(k) of the Federal Food, Drug, and Cosmetic Act or 351 of the Public Health Service Act.

fda form 3674 download

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What is the main purpose of the FDA?

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.

Form 3674 pdf-2025

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