13 February 2019 - Ensuring the safety of our nation’s drug supply is a cornerstone of our consumer protection mission.
One of the fundamental elements of overseeing the quality and safety of pharmaceuticals is having a clear understanding of the specific processes and technologies used to manufacture drugs throughout their lifecycle. This starts before a product is even approved and brought to market, with the FDA’s premarket (or pre-approval) review of drug applications.
This includes a careful review of information about product and manufacturing quality, as well as, in many cases, premarket inspections of a company’s intended manufacturing facility to ensure compliance with good manufacturing practices and other regulations. Overseeing how drugs are produced is a key component of ensuring the quality and safety of these products.