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FDA Issues Final Guidance on Civil Money Penalties Relating to

January 19, 2021

FDA has issued a final guidance document on Civil Money Penalties Relating to the Data Bank.  This draft guidance was first issued in 2018 and has been revised with industry comments.

Section 303(f)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to assess civil money penalties against submitters of certain applications and submissions to FDA regarding drug who violate requirements to submit required information, including information required for

The guidance covers:

  • How FDA intends to identify whether responsible parties have failed to submit required information, or have submitted false or misleading information (including results information)
  • Circumstances under which a Center may decide to seek civil money penalties against a responsible party or submitter
  • Procedures that apply when a Center seeks civil money penalties, and what civil money penalty amounts may be assessed

FDA revised the guidance to clarify that FDA does not intend to include on its Lists of Inspectional Observations, Forms FDA 483, any inspectional observations regarding potential violations relating to the data bank. 

However, information that is collected by an investigator regarding potential violations of such requirements will be included in an Establishment Inspection Report and provided to the relevant Center for further evaluation.

The Centers intend to identify potential violations of the FD&C Act’s requirements relating to the data bank in part through evidence collected during inspections conducted as part of the FDA’s BIMO program.

Generally, FDA’s BIMO activities are associated with the submission of a research or marketing application or are a part of the Agency’s investigation of a complaint. When evaluating potential violations identified during these activities, FDA intends to utilize a risk-based approach to determine the situations in which Pre-Notice Letters will be issued, consistent with FDA’s public health mission, and how the Agency approaches its other compliance programs. Submitters with a pattern of noncompliance are more likely to be identified.

The FDA intends to take into consideration any corrective action taken by a responsible party or submitter after receiving a Notice of Noncompliance.

The guidance further explains that the FDA intends to post Notices of Noncompliance on its website and to transmit the Notices of Noncompliance to the National Institutes of Health (NIH). As a result, the public will experience greater transparency when seeking to understand the accuracy of information posted on

It’s clear that the FDA is increasing scrutiny of information and preparing to apply monetary penalties (or hoping that the threat of such will increase compliance). 

The Ennov CTMS solution is built on a principle of collecting timely and accurate data to drive submissions. Please contact us if you would like to learn more about how we can assist you in generating timely and accurate submissions.

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