Get HHS Form FDA 3674 2024

The Food and Drug Administration (FDA) is an HHS agency that regulates clinical investigations of products under its jurisdiction, such as drugs, biological products, and medical devices.

Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer/patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

FDA developed Form FDA 3674 which may be used to provide certification. The certification must accompany certain human drug, biological product and device applications and submissions.

Form FDA 1571: Coversheet for all IND submissions. The 1571 must be signed by the Sponsor of the IND. Form FDA 1572: Statement of Investigator. The 1572 must be signed by the Principal Investigator of the clinical trial.

A Form FDA 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed conditions that in their judgment may constitute violations of the Food, Drug, and Cosmetic (FD&C) Act and other Acts or regulations.

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 significant.

What to Report on Form FDA 3500 and FDA 3500B Voluntary Adverse Event Report Form. FDA Form 3500 should be used by healthcare professionals and FDA Form 3500B should be used by patients or consumers for voluntary reporting of adverse events noted spontaneously in the course of clinical care.

Learn more about Clinical Trials. Drug developers, or sponsors, must submit an Investigational New Drug (IND) application to FDA before beginning clinical research.