- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice of Regulatory AffairsOffice of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical PracticeCenter for Drug Evaluation and ResearchCenter for Devices and Radiological HealthCenter for Biologics Evaluation and Research
This guidance document is intended to describe the current thinking of FDA's Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) (hereafter, "Center" or collectively, "the Centers"), regarding civil money penalties under section 303(f)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). That section authorizes FDA to assess civil money penalties against responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products (hereafter, "submitters") who violate applicable FD&C Act prohibitions relating to requirements under section 402(j) of the Public Health Service Act (42 U.S.C. 282(j)), including its implementing regulations in 42 CFR Part 11, to submit registration and/or results information to the ClinicalTrials.gov data bank and/or certain certifications to FDA.
The guidance document addresses the following questions:
- How do the Centers intend to identify whether responsible parties have failed to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank or submitted false or misleading information to the data bank, or whether submitters have failed to submit to FDA the certification required by section 402(j)(5)(B) of the Public Health Service Act (PHS Act) or knowingly submitted a false certification to FDA?
- Under what circumstances may a Center decide to seek civil money penalties against a responsible party or submitter?
- What procedures apply when a Center seeks civil money penalties?
- What civil money penalty amounts may be assessed for (1) failing to submit required clinical trial registration and/or results information to the ClinicalTrials.gov data bank, (2) submitting false or misleading information to the data bank, (3) failing to submit the required certification to FDA, or (4) knowingly submitting a false certification to FDA?
In general, FDA's guidance documents do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2018-D-0787.