Quiz 5 Law History Flashcards
What is the best definition of drugs according to the FDA?
Drugs are for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man
Which statement is incorrect about drugs regulated by FDA?
Substances used for diagnosis of diseases are not considered as drugs
What does not apply to patent medicines?
Patent medicines were sold through internet pharmacies
The tetanus-contaminated diphtheria antitoxin that resulted to deaths of children in 1901 and that led to the passage of the Biologics Control Act of 1902 was produced from:
The blood serum of a horse
Dr. Harvey Wileys clinical trials with the poison squad tested the toxic effects of food preservatives and led to the Pure Foods and Drug Act of 1906. What was not true of that particular clinical trial?
Carcinogenic or mutagenic studies were done in animals prior to testing in humans
Harvey Wileys clinical trials with the poison squad tested the toxic effects of food preservatives. Which of these still widely used preservative was not banned under the Pure Food and Drug Act of 1906 and still used today? For the long exam, you will need to know all preservatives which are still used today and those that are now banned,
Potassium nitrate
In legal usage, amendments refer to:
any additions or changes to parts of an existing law or bill
What does not have to do with the Federal Food Drugs and Cosmetic Act of 1938?
A penicillin analog used in drug formulation
Which of the following is least relevant to the Kefauver-Harris Amendments of 1962?
Patent medicines with unknown ingredients
The death from Children’s Tylenol laced with cyanide led to certain requirements for tamper-evident packaging. What is not part of tamper-evident packaging requirement for over-the-counter (OTC) drugs as mandated in the Federal Anti-tampering Act of 1982?
Labels should clearly state that adult supervision is required for tampering
What is not true of the Hatch-Waxman Act of 1984?
Large and expensive clinical trials, similar to that of branded drug trials, are required for marketing approval of the copycat drugs
What applies to the Prescription Drug Marketing Act of 1987?
The Act arose from concerns about illegal sales of excess pharmacy inventories
What was the FDA’s response to the urgent need of patients for another effective drug against AIDS?
Allowed patients pre-approval access to drugs still in clinical trials that are not yet FDA-approved for marketing
The Prescription Drug Users Fee Act of 1992 was passed mainly to:
Shorten the time for new drug review and marketing approval
The drug, Vioxx, a widely used drug indicated for arthritis, was withdrawn from the market after it was linked to:
Heart problems
