Investigational New Drug (IND) Application
An Investigational New Drug (IND) application is a request submitted to the U.S. Food and Drug Administration (FDA) by a company wishing to test a new drug on humans. It includes data from laboratory and animal studies, outlines the proposed plan for human trials, and ensures safety measures are in place. Approval of the IND allows researchers to start clinical trials to evaluate the drug's effectiveness and safety in people. This process is crucial for bringing new medications to market while safeguarding public health.
Additional Insights
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An Investigational New Drug (IND) application is a request submitted to the U.S. Food and Drug Administration (FDA) by a pharmaceutical company or researcher. It seeks permission to start clinical trials on a new drug in humans. The application includes data on the drug's safety, manufacturing details, and the proposed research plan. The FDA reviews the IND to ensure the drug can be tested safely in people. If approved, the research can proceed, aiming to determine the drug's efficacy and safety for potential approval for public use.