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drugs class - Marketing a new drug must turn in...

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Marketing a new drug: must turn in IND (application to investigate a new drug in human clinical trials) -If the FDA authorizes the use of the drug in humans, the company can move into the first of 3 phases of clinical investigation: Phase 1 (encompass studies with very small amts of the drug on a limited number of healthy ppl. At this stage the researchers are primarily interested in learning how their drug is absorbed and excreted in healthy people as well as the side effects it may trigger) -phase 2: of the human studies involved the patients who have the condition the candidate drug is designed to treat. -phase 3: is quite extensive and involved administering the drug to larger numbers of indiv than in phase 2 (1000-5000) with the disease or symptom for which the drug is intended for -1994 dietary supplement health and education act cleared up many of those issues. For one thing, it broadened the definition of dietary supplements to include not only vitamins, minerals, and proteins but also herbs and herbal extracts. The labels are not allowed to make unsubstantiated direct claims, such as
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