The FDA may require the manufacture of a drug to post a prominent "black box" warning when:

Question

a. The drug receives IND status (Investigational new drug)
b. Following phase one human testing
c. Unlabeled uses of the drug occur
d. A problem may arise that may lead to death or severe injury if the medication is used

Answer 1

d
Rationale: a. A drug gains the status of investigational new drug when it has completed its preclinical testing phase and is ready for human testing.
b. The primary purpose of phase one testing is to determine the pharmacokinetics, toxicity, and safe dose in humans.
c. Unlabeled uses of a drug may occur when a physician or group of peers determines that a drug that has indications for one disorder inadvertently is beneficial for another disorder that it was not given an indication for during the human testing phases.
d. The FDA requires a prominent "black box" warning when the use of a prescribed drug may lead to death or injury as a result of its use.