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Abrams Table 1-1
UTHSCSA N3312 Abrams American Drug Laws and Amendments
| Question | Answer |
|---|---|
| 1906 Pure Food and Drug Act | established official standards and requirements for accurate labeling of drug products and established the forerunner to the FDA; first American Drug Law |
| 1912 Sherley Amendment | prohibited fraudulent claims of drug effectiveness |
| 1914 Harrison Narcotic Act | restricted the importation, manufacture, sale, and use of opium, cocaine, marijuana, and other drugs that the Act defined as narcotics |
| 1938 Food, Drug, and Cosmetic Act | revised and broadened FDA powers; gave the FDA control over drug safety; required proof of safety from the manufacturer before a new drug could be marketed; created USP labeling; established penalties for fraudulent claims and misleading labels |
| 1945 Amendment | required governmental certification of biologic products, such as insulin and antibiotics |
| 1952 Durham-Humphrey Amendment | designated drugs that must be prescribed by a physician and dispensed by a pharmacist (e.g. controlled substances, drugs only for use under supervision of a health care provider, and drugs limited to prescription use) |
| 1962 Kefauver-Harris Amendment | required manufacturers to provide evidence that a drug was effective for claims and conditions identified in the product’s labeling; gave the federal government the authority to standardize drug names |
| 1970 Comprehensive Drug Abuse Prevention and Control Act; Title II, Controlled Substances Act | regulated distribution of narcotics and other drugs of abuse; categorized these drugs according to therapeutic usefulness and potential for abuse; updated or replaced all previous laws regarding narcotics and dangerous drugs |
| 1978 Drug Regulation Reform Act | established guidelines for research studies and data to be submitted to the FDA by manufacturers; shortened the time required to develop and market new drugs |
| 1983 Orphan Drug Act | decreased taxes and competition for manufacturers who would produce drugs to treat selected serious disorders affecting relatively few people |
| 1987 Act | established new regulations designed to speed up the approval process for high-priority medications |
| 1992 Prescription Drug User Fee Act | allowed the FDA to collect user fees from pharmaceutical companies, with each new drug application, to shorten the review time (could hire more staff); specified a review time of 12 months for standard drugs and 6 months for priority drugs |
| 1993 NIH Revitalization Act | requires inclusion of women and minorities in NIH-funded research studies, including Phase III clinical drug trials |
| 1997 FDA Modernization Act | updated regulations of biologic products; increased patient access to experimental drugs and medical devices; accelerated review of important new drugs; allowed drug companies to disseminate information about off-label uses and costs of drugs |
| 2002 Best Pharmaceuticals for Children Act | encouraged pharmaceutical companies to conduct studies and label drugs for use in children; provided funds for 5 years for pediatric drug studies |
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