New FDA product-specific guidances on generic drug development

Today, the US Food and Drug Administration published a new batch of draft product-specific guidances (PSGs) for developing generic drugs and generating evidence for abbreviated new drug applications (ANDAs).

The FDA publishes PSGs to help facilitate generic drug development, streamline ANDA assessment, and support greater access to generic drugs that are as safe and effective as their brand name counterparts and meet the same high-quality standards. Improving access to generic medicines supports the agency’s mission to advance public health, as outlined in its Drug Competition Action Plan.