Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to the Food and Drug Administration, and Food and Drug Administration Staff; Availability

概要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry and other responsible parties entitled "Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank; Guidance for Responsible Parties, Submitters of Certain Applications and Submissions to FDA, and FDA Staff." The guidance provides the current thinking of FDA's medical product Centers--the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health--regarding civil money penalties that may be assessed under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for violations of the requirements to submit clinical trial registration and results information to the ClinicalTrials.gov data bank and certain certifications to FDA.