Generic Drug Review Process

An important part of CDER's mission is to assure that safe and effective generic drugs are available to the American people. This work is accomplished in CDER's Office of Generic Drugs (OGD). The information below provides an understanding of how CDER works to assure the safety and effectiveness of generic drug products.

	Generic Drug Review Process- An interactive chart that provides an overview of CDER's abbreviated new drug application (ANDA) review process, and how CDER determines the safety and bioequivalence of generic drug products prior to approval for marketing.
	OGD Home Page- For further information on CDER's generic drug program, visit the Office of Generic Drugs home page.