Question

The adverse reactions area of the Highlights section of a package insert contains a phone number and web address for FDA's MedWatch program

A) True
B) False

Answer 1

The statement is true; the adverse reactions area of the Highlights section of a package insert indeed contains contact information for reporting to FDA's MedWatch program, which is vital for monitoring drug safety post-approval.

Step-by-step explanation:

The statement that the adverse reactions area of the Highlights section of a package insert contains a phone number and web address for FDA's MedWatch program is true. The MedWatch program is the FDA Safety Information and Adverse Event Reporting Program, which allows health professionals and consumers to report adverse events related to drugs. It's a critical component of postmarket surveillance, where unexpected serious and fatal adverse events are reported within certain timeframes to ensure continuous monitoring of drug safety after approval.