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10 Cards in this Set
- Front
- Back
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Federal Food Drug and Cosmetic Act (FDCA) 1938 |
FDA regulates food, drug and cosmetic safety. Drugs tested for safety-- labels mandated, directions, warnings of addiction |
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Controlled Substances Act (CSA) 1970 |
Creation of drug enforcement administration. Consolidation of federal laws for drugs of abuse. |
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Durham-Humphrey Amendment of 1951 |
Prescription drugs legalized-- medical/pharmacist necessary |
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Kefauver-Harris Amendment |
Require proof of efficacy and safety. FDA control of prescription drug advertising. Informed consent of study patients. Reporting of adverse effects |
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Orphan Drug Act of 1983 |
Financial incentives for developing orphan drugs-- diseases affecting <200,000 people (since expensive new drug application) |
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Prescription Drug User Fee Act 1992 |
Manufactureers pay user fees for certain drug applications--> decreased review time by FDA |
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Health Insurance Portability and Accountability Act of 1996 (HIPAA) |
protect privacy of personal health info |
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FDA Modernization Act of 1997 (FDAMA) |
include minorities and children in clinical trials. marketing incentives for studying drugs in children |
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Combat Methamphetamine Epidemic Act of 2005 |
regulates selling of list 1 chemicals: ephedrine, pseudoephedrine, and phenylpropanolamine |
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Patient Protection and Affordable Care Act/ Biologics Price Competition and Innovation Act of 2009 |
abbreviated approval path for biological products biosimilar and interchangeable with FDA approved biological products |
