Press release: “The U.S. Food and Drug Administration (FDA) today issued final guidance that describes FDA’s current approach to communicating drug safety information, including emerging safety information, to the public. The guidance also includes the factors that influence when such information is communicated. Important drug safety information has the potential to alter the benefit/risk analysis for a drug in a way that can affect decisions about prescribing or taking the drug. The guidance affirms the agency’s commitment to communicate important drug safety information in a timely manner, including in some situations when the agency is still evaluating whether to take any regulatory action.”