The Critical Path Institute's approach to precompetitive sharing and advancing regulatory science

Abstract

Many successful large industries, such as computer-chip manufacturers, the cable television industry, and high-definition television developers,(1) have established successful precompetitive collaborations focusing on standards, applied science, and technology that advance the field for all stakeholders and benefit the public.(2) The pharmaceutical industry, however, has a well-earned reputation for fierce competition and did not demonstrate willingness to share data or knowledge until the US Food and Drug Administration (FDA) launched the Critical Path Initiative in 2004 (ref. 3).