Question

The FDA reviews and approves which of the following written information for patients? (Select ALL that apply.)

A. Patient package inserts (PPI)
B. Mailers for OTC medications
C. Consumer medication information (CMI)
D. Med Guides
E. TV commercials for OTC medications

Answer 1

The FDA reviews and approves patient package inserts (PPI), consumer medication information (CMI), and Med Guides for patients.

Step-by-step explanation:

The FDA reviews and approves the following written information for patients:

• Patient package inserts (PPI): These are leaflets that provide important information about a prescription medication, including its uses, potential side effects, and instructions for use.
• Consumer medication information (CMI): CMI leaflets are provided with nonprescription (over-the-counter) medications and contain information on proper use, warnings, and precautions.
• Med Guides: Med Guides are educational materials that are required to be provided with certain prescription medications that have serious risks or require specific patient instructions.

Therefore, the FDA reviews and approves PPIs, CMIs, and Med Guides for patients.