An IND, or Investigational New Drug Application, is a type of application submitted to the FDA (Food and Drug Administration) to request permission to administer an investigational drug to humans. An investigational drug is a drug that is not yet approved for sale in the United States, but is being studied in clinical trials to evaluate its safety and efficacy.
When a company or individual wants to begin testing an investigational new drug in humans, they must first submit an IND to the FDA. The IND application includes information on the investigational drug, such as its chemistry, manufacturing, and controls (CMC), as well as preclinical study results and the proposed clinical trial protocol. It also includes a description of any risks associated with the drug and a plan for monitoring the safety of trial participants.
The FDA reviews the IND application to ensure that the proposed clinical trials will not place trial participants at an unreasonable risk and that the drug's potential benefits outweigh its potential risks. Once the IND is approved, the sponsor can begin testing the drug in human subjects. The FDA also conducts inspections to verify that the sponsor is following the approved protocol and that the trial participants are not being placed at risk.
The IND process is designed to protect the safety of human subjects participating in clinical trials, while allowing for the development and approval of new drugs. It also aims to provide sponsors with a clear pathway to obtain FDA approval for investigational new drugs, so that they can bring new therapies to the market as soon as possible.
In summary, An IND (Investigational New Drug Application) is a type of application submitted to the FDA to request permission to administer an investigational drug to humans. An investigational drug is a drug that is not yet approved for sale in the United States but is being studied in clinical trials to evaluate its safety and efficacy. When a company or individual wants to begin testing an investigational new drug in humans, they must first submit an IND to the FDA. The FDA reviews the IND application to ensure that the proposed clinical trials will not place trial participants at an unreasonable risk and that the drug's potential benefits outweigh its potential risks. Once the IND is approved, the sponsor can begin testing the drug in human subjects.
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