FORM FDA 3674 - FDA-3674DynSecExt04-15-2024-2-2025

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The document is a certification form (Form FDA 3674) required by the Food and Drug Administration (FDA) for compliance with the ClinicalTrials.gov Data Bank under U.S. law. It must accompany various types of applications or submissions related to drugs, biologics, or devices, confirming whether clinical trial data is referenced and if applicable requirements have been met. The form includes sections for sponsor information, product details, application type, and a certification statement regarding clinical trials.

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When to submit a clinical study report to FDA?

The applicant should submit a requested abbreviated or full study report within 60 days of receiving a request (30 days for priority applications).

What is the purpose of the 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.

Is FDA approval needed for clinical trials?

All investigator-initiated clinical trials must register on ClinicalTrials.gov to comply with federal FDA requirements outlined in FDA 42 CFR 11 (Final Rule) and/or other federal agencies and departments policy or requirements. Studies that fall under multiple registration requirements only need to be registered once.

Do samples need to be reported to the FDA?

In general, this means that both manufacturers and ADRs of applicable drugs should submit drug sample information to FDA. We recognize that there may be instances when a manufacturer and ADR both have records regarding the same drug sample request or distribution.

What is FDA Form 3674 used for?

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.

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

Is a clinical study report mandatory?

Under this policy , every clinical trial funded in whole or in part by NIH is expected to be registered on ClinicalTrials.gov and have summary results information submitted and posted in a timely manner, whether subject to FDAAA 801 or not.

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

After the trial ends, researchers must submit study reports. This process continues until the developer decides to end clinical trials or files a marketing application. Before filing a marketing application, a developer must have adequate data from two large, controlled clinical trials.

FORM FDA 3674 - FDA-3674DynSecExt04-15-2024-2-2025

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