Fetus: The unborn offspring from the end of the 8th week after conception (when the major structures have formed) until birth. Up until the eighth week, the developing offspring is called an embryo.
Approved drug: A medication approved for marketing. In the US, the Food and Drug Administration (FDA) must approve a substance as a drug before it can be marketed. The approval process involves several steps including pre-clinical laboratory and animal studies, clinical trials for safety and efficacy, filing of a New Drug Application by the manufacturer of the drug, FDA review of the application, and FDA approval/rejection of application.
Claritin's approval for OTC marketing was based on FDA's criteria for determining appropriate drugs for OTC use - namely that the drug in question treats a condition that consumers can diagnose and manage themselves; that the drug is sufficiently safe for use by consumers without direct prescriber supervision; and that the drug's label explains potential adverse effects and conditions of use with clear and understandable directions.
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