United States v. Palazzo: FDA turns up the heat even further
On February 6, 2009, the U.S. Court of Appeals for the Fifth Circuit ruled in United States v. Palazzo that a clinical investigator can be held criminally liable for failing to comply with regulations of the U.S. Food and Drug Administration (FDA) that impose record-keeping and reporting requirements for clinical studies
This case is striking for two reasons:
First, it creates the firm precedent that noncompliance with the GCP record- keeping requirements contained in FDA regulations can result in criminal penalties
Second, this case clearly illustrates that the FDA and the U.S. Department of Justice (DOJ) are actively expanding the types of criminal charges that they can bring when they identify noncompliance during the conduct of clinical trials
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