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9 Cards in this Set
- Front
- Back
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approved new drug
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a drug that is alresady approved and on the market but is considered "new" because:
-new indication -new substance -combo of drug substances -changed proportion -dosage, administration, mwthod, etc. are changed *must undergo the IND process |
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unapproved indications (off labeled use)
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a disease state or health condition that is treated by a specific drug, but the drug is not approved by the FDA for this disease state
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investigational new drug (IND)
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a drug that is in clinical phases I-III
*FDA may end the testing of an IND at any time if studies show that the drug is too toxic under the agency's benefit/risk ratio criteria; FDA decision is final and not subject to appeal or judicial review |
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new drug
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a drug that has not been seen previously or an approved drug that with a new indication, new substance, combo of substances, changed proportion, or change in dosage, administration, method, etc.
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new drug application (NDA)
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a compilation of all the info obtained during the IND process
-contains a complete evaluation of the drug's safety and efficacy (msay be 100,000-200,000 pages of summary and raw data) *includes details of drug chemistry, preclinical studies, manufacturing processes, clinical studies, labeling, and packaging. |
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abbreviated new drug application (ANDA)
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Protects the manufactuers of generic drugs from having to conduct complete safety and efficacy tests for thier products as long as:
-bioequivalence and bioavailability requirements are met -manufacturing methods and control, labeling are similar/identical |
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full-disclosure advertisement
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drug advertisement that is required by law to disclose all the relevant information about a drug to the health professional or patient/consumer viewing the ad
-must meet "true statement" requirement ex: tv ads, prof journal ads |
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reminder advertisement
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advertisement that reminds people of the name of a drug, but does not disclose the indication or dose of the drug
ex: pen, notepads, magnets) |
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direct-to-consumer advertising
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drug advertising that targets the consumer directly
-tv ads -magazine ads *not subject to specific federal regulations *uses the same laws and regulations that apply to health care professional ads -"adequate provision" for tv ads--> requirement for brief summary, fast talking at the end *2 categories are product specific and non-product specific |
