A novel drug, ready to be tested for safety and efficacy in people.

Before a new drug or biological product can be tested on people in the USA, an Investigational New Drug (IND) application must be made to the US Food and Drug Administration (FDA).

An IND application must include information on safety in animal models, on manufacturing processes and quality assurance (CMC), the design of the proposed clinical studies, and the qualifications of the investigators due to carry out the study.

The IND process is designed to enable regulators to assess whether a drug is safe to test in humans and has promise as a potential treatment.

In Europe, a Clinical Trial Application (CTA) must be made to national regulatory agencies to secure approval for studies on humans.