News & Events > The Generic Drug Approval Process

News & Events > The Generic Drug Approval Process

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

Talking to Ted Sherwood, Director, Office of Regulatory Operations, Office of Generic Drugs, Center for Drug Evaluation and Research 

Generic drugs are copies of innovator or brand-name prescription drugs and make up about 88 percent of prescriptions filled in the United States. Brand-name drugs must demonstrate their safety and effectiveness through expensive and time-consuming research and development programs, including clinical studies. In contrast, generic drug developers can use data from their brand-name counterparts, resulting in much less expensive development programs and affordable access to treatments for many patients and consumers.

FDA requires a generic drug company produce enough data to demonstrate it can make a drug that can be appropriately substituted for its brand-name counterpart. The challenge to the generic drug maker is to prove to FDA that the generic version is substitutable with a brand-name drug that has been shown to be safe and effective. FDA’s challenge is to carefully review that data to ensure it proves the same thing. Let’s look at how both do their job.

For more information, please visit: The Generic Drug Approval Process.