Term
| Kefauver-Harris Amendment |
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Definition
| established that drugs must be efficacious, established good manufacturing practices, moved jurisdiction of prescription drug advertisement to the FDA instead of the FTC |
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Term
| Medical Device Amendments of 1976 |
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Definition
| required devices to be classified by function, required premarket approval, establishment of performance standards, conformance with GMP, adherence to rcord and reporting requirements |
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Term
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Definition
| provides tax/licensing incentives for manufacturers that produce and market drugs for rare diseases and conditions effecting 200,000 people or less |
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Term
| Drug Price Competition and Patent Term Restoration Act of 1984 |
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Definition
| streamlined approval process for generic drugs hastening their introduction to market and encouraging companies to make new drugs |
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Term
| Prescription drug marketing act of 1987 |
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Definition
| Regulated drug samples by requiring record keeping requirement and sales restrictions |
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Term
| The Generic Drug Enforcement Act of 1992 |
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Definition
| established penalties for and FDA employees who accept bribes to speed up the drug approval process |
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Term
| Prescription Drug User Fee |
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Definition
| provided extra funds to the FDA to increase workforce and cover increasing costs of the drug approval process; also discouraged companies from submitting applications for drugs unlikely to win approval |
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Term
| Nutrition Labeling and Education Act of 1990 |
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Definition
| established nutrition fact labels on food |
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Term
| FDA Modernization act of 1997 |
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Definition
| streamlined the drug approval process, allowed fast tracking of drugs indicated for serious or life threatening illnesses, established inactive ingredient labeling for OTCs, established FDA's mission statement |
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Term
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Definition
| articles used for food or drink for man or other animals, chewing gum, or any articles used for components of any such article |
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Term
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Definition
| anything listed in the pharmacopeia(s), articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; articles (other than food) intended to affect the structure oor any function of the body of man or other animals; or any articles used as a component of any of the above articles |
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Term
| Dietary Supplement Health and Education Act of 1994(DSHEA) |
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Definition
| created the dietary supplement category and altered the FDA's ability to regulate dietary supplements; mandates that the FDA regulates dietary supplements more as a food than a drug by not requiring premarket approval and allowing the manufacturer to determine if the supplement is safe by providing evidence to such effect |
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Term
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Definition
| a product intended for ingestion that is intended to supplement the diet and contains any one or more of the following: vitamin, mineral, herb/botanical, amino acid; a dietary substance intended for use by humans to supplement the diet by increasing the total dietary intake; a concentrate metabolite, constituent extract, or combo of the previous |
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