The primary factors behind FDA holds of 2023

18 January 2024

While 2023 saw the approval of many notable new drugs by the US Food and Drug Administration (FDA), the past year also featured many holds being imposed on clinical trials.

The FDA may impose a clinical hold on a Phase I study for a variety of reasons, including:

Identification of unreasonable or significant risk to subjects
A lack of sufficient qualifications in clinical investigators
Clinical investigator misconduct
Misleading or incomplete investigator brochure.

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