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Term of the Day
Informed consent is the process in which a health care provider educates a patient about the risks, benefits, and alternatives of a given procedure or intervention. The patient must be competent to make a voluntary decision about whether to undergo the procedure or intervention.
Investigational New Drug (IND)
The Investigational New Drug (IND) is a regulatory filing submitted to the FDA (Food and Drug Administration) in the United States prior to conducting clinical trials of a new drug in humans.The IND application contains information on the drug substance, including its composition, manufacturing process, and quality control testing results. It also includes data from non-clinical studies, such as animal toxicology and pharmacology data, as well as a plan for clinical trials in humans.The purpose of the IND application is to provide the FDA with sufficient information to determine whether the proposed clinical trials of the new drug are safe and scientifically sound, and whether the potential benefits of the drug outweigh the potential risks.The IND application is typically filed by the sponsor or developer of the new drug, and must be reviewed and approved by the FDA before the clinical trials can proceed. The FDA may require additional information or changes to the clinical trial plan before granting approval of the IND application.