FDA: New Critical Path Report Highlights Research Needed to Foster Generic Drug Development
The U.S. Food and Drug Administration (FDA) today issued the "Critical Path Opportunities for Generic Drugs" report identifying many of the unanswered scientific questions that impede the development of generic versions of commonly used drugs.
The report is part of FDA's Critical Path Initiative, established in 2004 to discern what challenges exist in moving a promising drug, biologic or device along the critical path from discovery, or proof of concept, to a marketable product. Solving these challenges will require the expertise and input of many groups, including scientists from universities, patient groups, government, industry, associations and other private organizations.