Avoiding Major Reasons for a Clinical Hold by FDA

Posted 01 January 2009 | By William Sietsema, PhD 

The term "clinical hold" can strike fear into the heart of even the most seasoned regulatory professional. It is not always possible to avoid these difficult situations, but well-prepared project teams are able to anticipate potential issues with the US Food and Drug Administration (FDA) and can understand and manage the risks. This article reviews regulations related to clinical holds, and then discusses the most common reasons for clinical holds, grouped by chemistry, human efficacy and safety, and pharmacology/toxicology, and discusses the impact of a pre-IND meeting on the probability of a clinical hold.

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