FDA’s Financial Disclosure Regulations: Careful Compliance in a Changing Landscape—Part I

| 01 November 2010

At first glance, compliance with US Food and Drug Administration (FDA) financial disclosure regulations set forth in 21 CFR Part 54 looks straightforward. The regulations are short, and the FDA guidance1 clarifies a number of issues. However, when faced with a mountain of invoices, financial data and contracts documenting financial ties to investigators and their institutions, trial sponsors often must make judgments about whether to disclose particular financial arrangements to FDA.


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