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Which is an investigational drug?

An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it. Scientists are trying to prove in clinical trials: If the drug is safe and effective.

What is IND and NDA?

The NDA application is the vehicle through which drug sponsors formally propose that the FDA approve a new pharmaceutical for sale and marketing in the U.S. The data gathered during the animal studies and human clinical trials of an Investigational New Drug (IND) become part of the NDA.

What is the difference between an experimental drug and an investigational drug?

An experimental drug is one that has been tested in the lab and with animals and approved for testing in people by the U.S. Food and Drug Administration (FDA). But, such a drug cant yet be advertised, sold, or prescribed. Experimental drugs may also be called investigational drugs.

What is the purpose of IND?

It is used in a clinical trial to investigate its safety and efficacy. The term also includes biological products that are used in vitro for diagnostic purposes. An IND application is a request for authorization from the FDA to administer an investigational drug or biological product to humans.

What is considered an investigational drug?

An Investigational New Drug (IND) is a drug or biological drug that has not been approved for general use by the FDA. It is used in a clinical trial to investigate its safety and efficacy. The term also includes biological products that are used in vitro for diagnostic purposes.

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