Civil Money Penalties Relating to the Data Bank

On 12 August 2020 the FDA announced the availability of the guidance for responsible parties, submitters of certain applications and submissions to FDA, and FDA staff.

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 (PHS Act), including its implementing regulations in 42 CFR part 11, to submit clinical trial registration and/or results information to the data bank and/or certain certifications to FDA.

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