define a “new drug”
drug is not generally recognized by qualified experts as safe and effective for use under the conditions recommended in the drug’s labeling *not to be confused with a new drug that just entered the market – an approved drug can become a new drug if dosing changes, combinations are added, new method of administration, new indication, new frequency, etc
A “new drug” is a medication or therapy that has not been previously approved for commercial use by a regulatory agency like the Food and Drug Administration (FDA) in the United States. It generally refers to a drug or therapy that is created with a new chemical formula or mechanism of action that has never been used for the treatment of a particular disease or condition. The development of a new drug involves rigorous testing to ensure its safety and effectiveness in treating the targeted disease or condition in humans. Once a new drug is approved by the regulatory agency, it can be prescribed by healthcare providers and made available to the public.
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