From 11 August, the US Food and Drug Administration (FDA) will adopt a new system for delivering less-than-stellar news to companies trying to bring new drugs to market, in a move intended to stop investors from over-interpreting its decisions (Nature 454, 265; 2008). The agency has ended its two categories of rejections: ‘approvable’ letters, if the drug needs more information or specific changes to win approval; and ‘not approvable’ letters, for applications with more major problems. In their place, a company whose drug is being rejected will receive a ‘complete response’ letter outlining an application’s deficiencies and what can be done to address them.

According to the agency, the change is intended to be a more consistent and neutral way of delivering the news that a drug application is not up to standard.