1. An unapproved drug is referred to by FDA as a _________ drug and an applicati
ID: 803569 • Letter: 1
Question
1. An unapproved drug is referred to by FDA as a _________ drug and an application for investigations of unapproved drugs are called __________ (by the abbreviation).
2. The initial impetus for the Food Drug and Cosmetic Act and the Pure Vaccine Act included:
a. Concerns about food containing nonfood substances, such as whole wheat flour mixed with sawdust
b. The need to create National Formularies
c. Poor sanitation in restaurants leading to “food poisoning”
d. Animal welfare for horses and goats producing serum therapies
e. All of the above
3. Once selected for as a candidate for human testing, most new drug candidates fail and are abandoned:
a. During phase 1
b. During phase 2
c. During phase 3
d. After a drug is marketed
4. With respect to patents, exclusivity, and vouchers
a. Fast Track Product approvals grant priority review vouchers
b. Orphan Drug Exclusivity was the first use of exclusivity granted by FDA
c. The Rare Pediatric Disease Voucher grants 6 months’ additional exclusivity to another product
d. HatchWaxman did not change patent terms, only exclusivity for new drugs and generic drugs
5. Which of the following is true:
a. FDA assures that pregnant women are enrolled in investigational drug trials before a product is used when there is substantial use in women
b. FDA has the authority to stop the distribution of an approved drug until studies are done in pregnant women
c. An entire IND drug development program can be put on hold, when the product is intended for a serious condition where there is unmet need, and the trials exclude women of childbearing potential
d. Animal studies of drug induced birth defects so imperfectly predict human birth defects that FDA does not require them
6. Warning Letters
a. Always mention adulteration or misbranding.
b. Can order a U.S. manufactured product seizure.
c. Can announce that foreign products will not be allowed entry through Customs.
d. Are advisory letters that do not require company responses.
e. Require Justice Department concurrence since they are enforcement actions
7. Which of the following does not require “unmet medical need”?
a. FDA Orphan Drug Approval
b. Fast Track Designation
c. Breakthrough Designation
d. Priority NDA Review
e. None of the above
Explanation / Answer
1) Investigational New Drug (IND)
2) e. All of the above
3) c.During phase 3
4) c. The Rare Pediatric Disease Voucher grants 6 months’ additional exclusivity to another product
5) c. An entire IND drug development program can be put on hold, when the product is intended for a serious condition where there is unmet need, and the trials exclude women of childbearing potential
6.a. Always mention adulteration or misbranding.
7. a. FDA Orphan Drug Approval
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