Approved drug
In the
United States, the
FDA approves
drugs. Before a drug can be prescribed, it must undergo an extensive FDA approval process. This process involves first testing the drug on animals or in medical labs. If found to be safe by the FDA and approved for the next phase of study, the drug is then tested for safety and effectiveness in humans (
clinical trials). The drug manufacturer then files a
New Drug Application to the FDA, which reviews the application and either approves or rejects it.
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Approved Drugs
In the United States, the Food and Drug Administration (FDA) must approve a drug before it can be marketed and sold to the public. The approval process involves several steps, including laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application (NDA) by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of the application.
See Also: New Drug Application
Source:
AIDSinfo, U.S. Department of Health and Human Services (DHHS)
APPROVED DRUGS
In the U.S., the Food and Drug Administration (FDA)<!-- (see) --> must approve a substance as a drug before it can be marketed. The approval process involves several steps including preclinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application<!-- (see) --> by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application.