What does IND stand for in a regulatory context?

In a regulatory context, IND stands for Investigational New Drug. This designation is crucial for the development of new pharmaceuticals. An Investigational New Drug Application is submitted to the regulatory authority, such as the FDA in the United States, to obtain permission to start clinical trials of a new drug in humans. The IND application includes data from preclinical studies, details about the drug's composition, manufacturing information, and a proposed clinical study protocol.

This designation is significant because it demonstrates that the sponsor has met certain requirements to ensure the drug's safety and efficacy before it can be tested in clinical settings. The IND process helps to safeguard participants in clinical trials, as it ensures there is an assessment of risk and ethical standards are maintained throughout the drug development process.

Understanding the role of an IND is essential for professionals in regulatory affairs, as it represents a critical step in bringing new medical products to market while ensuring compliance with legal and safety standards.