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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 FDA form for conflict of interest?

FDA believes that a clinical investigators financial interests could introduce bias into a study and affect the reliability of data submitted to FDA in support of a marketing application.

What are the other 3 forms used for the submission of the FDA for a NDA?

In the FDA Form 3410, SGEs list their financial interests that may create a conflict, and submit it to FDA for review. a conflict of interest? (cont.)

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

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 the FDA 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.

What is FDA Form 4003?

Instead, your company will receive an FDA Form 4003, FDA Inspection Records Request. Having the term inspection in the title of the form can be a little confusing, but it is not considered or counts as an inspection. However, the FDAs remote work will likely inform their onsite work during the actual inspection.

3674 form

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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.

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

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