What is a Clinical Hold?

A Clinical Hold refers specifically to an FDA order that suspends or delays a clinical investigation. This action is taken by the FDA when there are concerns related to the safety of the subjects involved, the adequacy of the study design, or compliance with regulatory requirements. Essentially, it is a protective measure ensuring that the welfare of participants is prioritized and that further data is required before allowing the investigation to continue.

In the context of clinical trials, the FDA may impose a Clinical Hold when reviewing an Investigational New Drug Application (IND) or if issues arise during ongoing trials. The hold requires sponsors to address the stated concerns before they can resume their study.

The other choices describe different aspects of regulatory processes and do not pertain to the specific role of a Clinical Hold. For example, the approval process for devices is related to how medical devices are evaluated for safety and efficacy before reaching the market, while an FDA order to proceed with an investigation is the opposite of a Clinical Hold, indicating that a trial can continue. Guidelines for manufacturing practices refer to standards that ensure products are produced consistently and safely but are unrelated to the concept of a Clinical Hold.