FDA Publishes New Draft Product-Specific Guidances to Accelerate Generic Drug Development

The U.S. Food and Drug Administration (FDA) has published a new batch of draft product-specific guidances (PSGs) to facilitate the development of generic drugs and streamline the assessment of abbreviated new drug applications (ANDAs). This action aims to improve access to generic medicines, aligning with the agency's mission to advance public health and the President's Executive Order on lowering drug prices. The batch includes 55 PSGs, with over 30 for products lacking approved ANDAs, including 15 for complex products.