Over the last decade, FDA has published a series of guidances that further articulate its views about how IND sponsors and NDA or Biologics License Application (BLA) applicants can comply with the regulations and statutes governing adverse event review and reporting. Unlike the statutes and regulations, however, guidances do not have the force and effect of law. Thus, if a company does not comply with the conduct described in a guidance, the company is not automatically violating the law and therefore subject to penalties. Conduct that is contrary to an FDA Guidance represents a risk however that the FDA will consider it a violation of law and attempt to bring an enforcement action. It is important, therefore, that companies understand these guidances and make carefully informed judgments that actions that differ from a guidance meet the requirements of the applicable law and regulations. Regardless, the guidances do provide IND sponsors and NDA applicants a clear idea of what FDA considers lawful conduct and, therefore, familiarity with them is critical.

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