Question

Which of the following pieces of information is found in the Clinical Studies section of the package insert?

A) How well a drug works for its approved indications
B) A drug's inactive ingredients
C) A drug's cancer risk
D) A drug's controlled substance classification

Answer 1

The Clinical Studies section of a package insert provides information on the drug's effectiveness, inactive ingredients, cancer risk, and controlled substance classification.

Step-by-step explanation:

The information found in the Clinical Studies section of the package insert includes:

1. How well a drug works for its approved indications: This section provides data on the effectiveness of the drug in treating the specific conditions it is approved for.
2. A drug's inactive ingredients: The package insert lists all the inactive ingredients present in a drug formulation.
3. A drug's cancer risk: If a drug has been associated with an increased risk of developing cancer, this information will be included in the Clinical Studies section.
4. A drug's-controlled substance classification: If a drug is classified as a controlled substance, this information will also be provided in this section.