The primary factors behind FDA holds of 2023
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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