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Click ‘Get Form’ to open the 3674 FDA form in the editor.
Begin by entering the 'Name of Sponsor/Applicant/Submitter' in the designated field. Ensure this matches exactly with what is listed on your application.
Next, input the 'Date of the Application/Submission' that this certification accompanies.
Provide complete contact information, including 'Address', 'Telephone', and 'Fax Numbers' for the sponsor/applicant/submitter.
In the 'Product Information' section, specify all relevant names for drugs/biologics or devices as required. Attach extra pages if necessary.
Select the type of application/submission by checking the appropriate box in section six.
If applicable, include any previously assigned IND/NDA/ANDA/BLA/PMA/HDE/510(k)/PDP number in section seven.
Fill in any serial number associated with your application in section eight, if available.
Check one of the boxes under 'Certification Statement' based on your situation regarding clinical trials.
If you checked Box C, provide any National Clinical Trial (NCT) numbers related to applicable clinical trials.
Sign and date where indicated to complete your submission. Ensure that all information is accurate and complete before finalizing.
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The document outlines Form FDA 3454, a financial disclosure certification for clinical investigators as required by 21 CFR Part 54, which mandates the reporting of financial interests that may bias clinical study outcomes.
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 the FDA form 3674?
Form FDA 3674--certifications to accompany drug, biological product, and device applications/submissions: guidance for sponsors, industry, researchers, investigators, and food and drug administration staff.
What is the difference between the FDA form 3455 and 3454?
Complete form 3454 if none of the investigators have any FDA required disclosures. Complete form 3455 if any clinical investigator has a financial disclosure that is docHub.
What is the FDA form 3794?
Abstract: Form FDA 3794, the Generic Drug User Fee Amendments Cover Sheet, requests the minimum necessary information from applicants to determine the total amount of generic drug user fees required, and to account for and track user fees.
3674 form
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Form FDA 3674 must accompany an application/submission, including certain amendments, supplements, and resubmissions, submitted under 505, 515, 520(m), or
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