Answer to Question 1
1,2
Rationale 1: The FDA created boxed warnings in order to regulate drugs with special problems.
Rationale 2: The black box warning is a primary alert for identifying extreme adverse drug reactions.
Rationale 3: Black box warnings are not a mechanism to differentiate a prescribed medication from an over-the-counter medication.
Rationale 4: It does not highlight the cost of the medication.
Rationale 5: It does not signify the medication as being generic.
Global Rationale: The FDA created boxed warnings in order to regulate drugs with special problems. The black box warning is a primary alert for identifying extreme adverse drug reactions. Black box warnings are not a mechanism to differentiate a prescribed medication from an over-the-counter medication, do not highlight the cost of the medication, and do not signify the medication as being generic.
Answer to Question 2
2
Rationale 1: Clinical investigation involves testing the drug on human subjects.
Rationale 2: Preclinical investigation involves laboratory research on nonhuman subjects.
Rationale 3: New Drug Application review occurs during human clinical trials.
Rationale 4: Post-marketing Studies occur after the drug is being used by the general population.
Global Rationale: Clinical investigation involves testing the drug on human subjects. Preclinical investigation involves laboratory research on nonhuman subjects. New Drug Application review occurs during human clinical trials. Post-marketing Studies occur after the drug is being used by the general population.