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18 Cards in this Set
- Front
- Back
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What year was the Kefauver-Harris Amendments? |
1962 |
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Why was the Kefauver-Harris Amendments created? |
in response to the discovery of birth defects caused by the thalidomide |
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What did the Kefauver-Harris Amendments require drug mfrs to provide? |
proof of the effectiveness and safety of their drugs before approval |
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What did the Kefauver-Harris Amendments require about drug advertising? |
to disclose accurate info about side effects and stopped cheap generic drugs being marketed as expensive "new" drugs |
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Name 3 other facts about Kefauvr-Harris Amendments. |
required drugs to be safe and effective increased more safety requirements (more research) established good manufacturing practices |
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What year was the Orphan Drug Act? |
1983 (January) |
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What does the Orphan Drug Act provide? |
incentives to drug mfrs to develop and market orphan drugs |
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What are orphan drugs? |
drugs used for treatment and prevention of rare diseases or conditions |
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What is the definition of a rare disease? |
one that effects less than 200,000 persons in the US or that affects more than 200,000 persons in US with no reasonable expectation that the cost of developing the drug and making it available will be recovered from the sale of the drug |
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What year was the Drug Price Competition and Patent Restoration Act? |
1984 |
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What is the Drug Price Competition and Patent Restoration Act also called? |
Hatch-Waxman Act |
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What did the Hatch-Waxman Act do? |
amended the FDCA and set forth the process by which would-be marketers of generic drugs can file Abbreviated New Drug Applications (ANDAs) to seek FDA approval of the generic |
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What was the the purpose of the Hatch-Waxman Act? (2) |
to reduce health care costs speed up approval of generic drugs by eliminating duplicate and unnecessary testing |
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Why was the Prescription Drug Marketing Act of 1987 enacted? |
to ensure that drug products purchased by consumers are safe and effective and to avoid the unacceptable risk to American consumers form counterfeit, adulterated, misbranded, sub potent, or expired drugs |
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Name 3 facts about the Prescription Drug Marketing Act of 1987. |
was necessary to increase safeguards in the drug distribution system to prevent the sale of ineffective or counterfeit drugs requires state licensing of prescription drug wholesaler distributions under federal guidelines pharmacies cannot dispense drug samples |
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What is the "Orange Book"? |
identifies drug products approved on the basis of safety and effectiveness by the FDA under the FDCA |
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What is the actual name of the "Orange Book"? |
Approved Drug Products with Therapeutic Equivalence Evaluations |
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How did it get the title "Orange Book"? |
It was first printed in October 1980 and the staff members in the Office of Generic Drugs had to choose a color for the cover. The project manager suggest orange because it was almost Halloween. |
