The US Department of Justice’s new policy of giving companies credit for voluntarily self-disclosing corporate misconduct has raised questions about whether communicating problems to the US Food and Drug Administration could count as timely disclosure.
DOJ Enforcement: Talking With US FDA Is Not Enough To Get Credit For Self-Disclosure
Remediation of a problem with FDA is one factor the DOJ considers in assessing whether a company gets credit for self-disclosure of misconduct prior to a criminal investigation, but it wants companies to come directly to the department to divulge wrongdoing.
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