Term
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Definition
- Prohibited adulturation and misbranding in interstate comerce
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Term
| Food, drug, and cosmetic act |
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Definition
- No new drugs can be marketed until proven safe under directions
- Lables must contain adequite directions for use and warnings for habit forming
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Term
| Durham Humphrey Amendment |
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Definition
- Established Rx and OTC drugs
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Term
| Kefauver-Harris Amendment |
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Definition
- Drugs must be proven safe & effective
- More extensive controls for clinical trials
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Term
| Drug price competition and Patent-term restoration act |
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Definition
- Streamlined generic drug approval process
- Gave patent extensions
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Term
| Prescription Drug Marketing act |
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Definition
- Required states to license wholesale drug distributors
- Samples
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Term
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Definition
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Term
| Nutrition labeling and education act |
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Definition
- nutrition labeling on food products
- Authorized health and disease prevention claims
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Term
| Diestary suppliment health and educations act |
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Definition
- Required FDA to prove suppliments unsafe before removing from market
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Term
| Food and drug administration modernization act |
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Definition
- fast track drug aproval process
- Safe harbor for manufactures to disseminate off-lable uses
- Created databank of clinical trials
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Term
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Definition
- increased funding to FDA
- Enhanced drug safety authority
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Term
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Definition
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Term
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Definition
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Term
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Definition
| Possibility of temporary ot reversible harm |
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Term
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Definition
| Not likely to be harmfull |
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Term
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Definition
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Term
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Definition
- General controls + Performance standards
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Term
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Definition
- General control + performance standards + premarketing approval
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