Efficient drug approval and monitoring must rely on sound regulatory science

The path to drug approval is long, hard and often perplexing. In recent months, the US Food and Drug Administration (FDA) has promised to bolster 'regulatory science', which aims to transform its decision-making process to be more efficient, transparent and accountable. However, diverse stakeholders, including patients, drug developers and the US Congress, will have to rise to the challenge of coordinating their priorities if this endeavor is to succeed.