Question

Which section of the package insert provides information on how well the drug works for its approved indication?

Select one:
A) Clinical Studies
B) Dosage and Administration
C) Indication and Usage
D) Product Description

Answer 1

The 'Clinical Studies' section of a package insert provides information on the drug's efficacy for its FDA-approved indications, demonstrating effectiveness and safety from clinical trials.

Step-by-step explanation:

The section of the package insert that provides information on how well the drug works for its approved indication is A) Clinical Studies. This section includes data from the clinical trials conducted to assess the effectiveness, safety, and dosing parameters of the drug.

These trials are often broken down into distinct phases, with phase I assessing safety and tolerability, phase II focusing on efficacy and dosing, and phase III expanding to larger populations to confirm effectiveness and monitor adverse reactions. The Clinical Studies section compiles the results from these trials to inform healthcare professionals and patients about the drug's efficacy and safety profile for its FDA-approved indications.