Meaning investigational new drug

What does investigational new drug mean? Here you find 3 meanings of the word investigational new drug. You can also add a definition of investigational new drug yourself

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investigational new drug


A substance that has been tested in the laboratory and has been approved by the U.S. Food and Drug Administration (FDA) for testing in people. Clinical trials test how well investigational new drugs work and whether they are safe to use. An investigational new drug may be approved by the FDA for use [..]
Source: cancer.gov

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INVESTIGATIONAL NEW DRUG


A drug or biological product that is used in a clinical trial but has not been approved by the Food and Drug Administration (FDA) (the drug is either not available for a doctor to prescribe or is available but has not been approved by FDA for the use being studied).
Source: clinicaltrials.gov

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investigational new drug


a drug or biological product subject to the FDA regulations at 21 CFR Part 312 including a drug not approved or a biological product not licensed by the FDA and a drug unapproved for its applied use
Source: vhcprojectimmunereadiness.com

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