Investigational New Drug (IND)

An investigational new drug (IND) is a drug that has not yet been approved by the U.S. Food and Drug Administration (FDA) for use in humans. INDs are typically used in clinical trials to determine the safety and efficacy of a new drug before it is marketed.

The FDA regulates the development and approval of INDs through its Center for Drug Evaluation and Research (CDER). To obtain an IND, a drug developer must submit a New Drug Application (NDA) to the FDA. The NDA must include information about the drug's chemistry, manufacturing, and controls; preclinical studies; and clinical studies.

The FDA reviews the NDA and may approve the IND if it finds that the drug is safe and effective for its intended use. The FDA may also require the drug developer to conduct additional studies before the IND can be approved.

Once an IND is approved, the drug developer can begin clinical trials to test the drug in humans. Clinical trials are conducted in phases, with each phase designed to answer specific questions about the drug's safety and efficacy.

Phase 1 trials are typically small studies that test the safety of a new drug in a small number of healthy volunteers. Phase 2 trials are larger studies that test the efficacy of a new drug in a larger number of patients with the disease or condition that the drug is intended to treat. Phase 3 trials are even larger studies that confirm the efficacy and safety of a new drug in a large number of patients.

If the results of clinical trials are positive, the drug developer can submit a New Drug Application (NDA) to the FDA for approval. The FDA reviews the NDA and may approve the drug for marketing if it finds that the drug is safe and effective for its intended use.

The IND process is a complex and lengthy one, but it is essential to ensure that new drugs are safe and effective before they are marketed to the public.