What does IND stand for in regulatory affairs?

What does IND stand for in regulatory affairs?

• A. Indirect New Device
• B. Investigational New Drug
• C. Initial New Development
• D. International New Drug

Answer: (B)

In regulatory affairs, IND stands for Investigational New Drug. This term refers to the designation by the U.S. Food and Drug Administration (FDA) that permits a pharmaceutical company to begin clinical trials of a new drug in humans. The IND application must provide detailed information about the drug's composition, manufacturing, and how it works, as well as data from laboratory and animal studies. This is a critical step in the drug development process, as it ensures that the proposed studies meet FDA requirements for safety and effectiveness before they can proceed. Understanding this designation is important for regulatory professionals, as it involves various compliance requirements and safeguards for participants in clinical trials. The process of submitting an IND application also involves careful planning and documentation to demonstrate that the drug is ready for testing in humans, which is vital for advancing new therapies and ensuring public health and safety.

In regulatory affairs, IND stands for Investigational New Drug. This term refers to the designation by the U.S. Food and Drug Administration (FDA) that permits a pharmaceutical company to begin clinical trials of a new drug in humans. The IND application must provide detailed information about the drug's composition, manufacturing, and how it works, as well as data from laboratory and animal studies. This is a critical step in the drug development process, as it ensures that the proposed studies meet FDA requirements for safety and effectiveness before they can proceed.

Understanding this designation is important for regulatory professionals, as it involves various compliance requirements and safeguards for participants in clinical trials. The process of submitting an IND application also involves careful planning and documentation to demonstrate that the drug is ready for testing in humans, which is vital for advancing new therapies and ensuring public health and safety.