The FDA Amendments Act (FDAAA) was passed in 2007 to address which aspect of drug safety?
A) Allowing pharmaceutical companies to identify off-label uses of medications approved for other uses
B) Evaluating drug safety information that emerges after a drug has been approved and is in use
C) Expediting the approval process of the U.S. Food and Drug Administration (FDA) so that needed drugs can get to market more quickly
D) Requiring manufacturers to notify patients before removing a drug from the market

Question

Quizplus · Accepted Answer

The FDAAA was passed to enable the Food and Drug Administration to continue oversight of a drug after granting it approval so that changes in labeling could be made as necessary and postmarketing risks could be tracked and identified. A provision of the FDA Modernization Act (FDAMA), passed in 1997, allows drug companies to promote their products for off-label uses as long as they promise to conduct studies to support their claims. Regulations to permit accelerated approval of drugs for life-threatening diseases were adopted in 1992 by the FDA. The requirement that drug companies notify patients 6 months before removing a drug from the market is a provision of the FDAMA.

The FDA Amendments Act (FDAAA) Was Passed in 2007 to Address