Self Check questions Flashcards
- What legislation established the five schedules of drugs having the potential for addiction?
b. Controlled Substances Act of 1970
- What legislation made a distinction between prescription and nonprescription drugs?
d. Durham-Humphrey Amendment of 1952
- What legislation required that prescription medications be dispensed in childproof containers?
a. Poison Prevention Packaging Act of 1970
- What legislation specifically identified the FDA as the enforcement body that would officially
approve all new drugs?
c. Federal Food, Drug and Cosmetic Act of 1938
- What legislation distinguished between drugs having abuse potential and drugs having none?
b. Controlled Substances Act of 1970
- What is the approximate ratio of the number of chemical compounds tested for activity as new
drugs to the number of chemical compounds that actually make it to the clinical testing stage?
C. 10,000 to 1
- What phase of drug testing determines the lethal dose of the chemical compound in
laboratory mice?
d. Short-term toxicity testing
- What type of test determines the potential for a test drug to cause cancer?
c. Carcinogenicity
- What type of test determines the potential for a test drug to cause birth defects?
a. Teratogenicity
- The IND application review by the FDA takes
c. one to two years
- A(n) ________ must be approved by the FDA before a drug can undergo clinical testing.
d.investigational new drug application (IND)
- A(n) ________ can’t be submitted to the FDA until the first three phases of clinical testing are
completed.
a. New drug application (NDA)
- A Phase 4 clinical study
c. is conducted after the drug is approved and marketed.
- A Phase ________ clinical test of a new drug starts immediately after the approval of an IND.
a. 1
- The application for approval of a generic equivalent is called a(n)
b. abbreviated new drug application (ANDA)
- The average drug has ________ years of exclusive sales and marketing before its generic
equivalent can be marketed and sold.
b. 12
- Approximately ________ of the 4000 or more prescriptions drugs currently being sold in the
United States are orphan drugs.
b. 300
- An “orphan drug” is a(n)
c. drug that’s used to treat rare disease.
- Which of the following conditions would most likely be treated with an orphan drug?
b. Lou Gehrig’s disease
- Which of the criteria listed below classifies an investigational new drug for “treatment use”?
b. No comparable alternative drug to treat the disease
- Which of the criteria listed below classifies an investigational new drug for “treatment use”?
c. Too expensive for the consumer to purchase
- Which amendment to the Federal Food, Drug, and Cosmetic Act of 1938 required all over-the counter
drugs to be both safe and effective?
d. Kefauver-Harris Amendment of 1962
- Prior to 1962, if an over-the-counter product had false or misleading information on the label,
it was categorized as
c. misbranded
- The current FDA review procedure for drugs sold without a prescription ensures that the
drug is
c. both safe and effective