Generic Drug Development

The FDA aspires to continually improve its pre-application interactions with applicants. To facilitate these interactions and to keep stakeholders as informed as possible, the agency provides the following resources and guidance on developing generic drug products and preparing and submitting abbreviated new drug applications (ANDAs)

To facilitate generic drug product availability and to assist the generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA regularly publishes product-specific guidances describing the Agency’s current thinking and expectations on how to develop therapeutic equivalents to specific reference listed drugs.