Get 3674 Fda Form 2020-2025
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How to fill out the 3674 FDA Form online
The 3674 FDA Form, Certification of Compliance with the Requirements of ClinicalTrials.gov Data Bank, is a crucial document required for certain applications and submissions in the healthcare sector. This guide aims to assist users in navigating the process of completing the form online effectively.
Follow the steps to complete the 3674 FDA Form online.
- Click ‘Get Form’ button to access the form and open it for editing.
- In the first field, enter the name of the sponsor, applicant, or submitter as listed on the application. Ensure accuracy for compliance.
- Enter the date of the application or submission that this certification accompanies in the designated field.
- Provide the complete address of the sponsor, applicant, or submitter, including the street number, state, and ZIP code.
- Input the telephone and fax numbers of the sponsor/applicant/submitter, making sure to include the area code.
- Fill in the product information. For drugs and biologics, include established and proprietary names; for devices, list common names, classifications, and model numbers.
- Select the type of application/submission associated with the certification by checking the relevant box.
- If the FDA has assigned an IND, NDA, ANDA, BLA, PMA, HDE, 510(k), PDP, or another number for the application, enter it in the appropriate field.
- Provide the serial number assigned to the application, if available. Leave the field blank if no serial number exists.
- In the certification section, check the box that accurately reflects whether the application involves clinical trials. There are three options: A, B, and C.
- If you selected Box C in the previous step, list any National Clinical Trial (NCT) numbers related to applicable clinical trials.
- Sign the certification by having the sponsor, applicant, or an authorized representative complete the signature field.
- Input the name and title of the individual who signed the form in the related fields.
- Provide the address, telephone, and fax numbers for the person identified in the signature.
- Enter the date when the certification is signed, which may differ from the application date.
- Once all fields are completed, ensure to save your changes, and then download, print, or share the finalized form as needed.
Complete your documentation online efficiently by following these steps.
The documents required for FDA approval can vary based on the specific application. Generally, you will need to include the 3674 FDA Form and other supporting documents that provide evidence of compliance with FDA regulations. Thoroughly reviewing the application guidelines on the FDA’s website is crucial for success.
Fill 3674 Fda Form
A certification accompany certain human drug, biological product, and device applications and submissions to FDA. FDA 3674 (PDF 2.6MB) Certification of Compliance Under 42 U.S.C. § 282(j)(5)(B), with Requirements of ClinicalTrials. FDA form 3674 – top of page 1. This form represents the Statement of the Investigator conducting clinical research under the IND application. This guidance describes the Food and Drug Administration's (FDA, we, or Agency) current thinking regarding the types of applications and submissions. Though FDA Form 3674 has been required for nearly all data submitted to the FDA since December 2007, it is not nearly as well recognized.
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