Early Communications About Ongoing Safety Reviews

 

As of January 29, 2010, FDA has transitioned to using one safety communication to provide the public with easy access to important drug safety information. These Drug Safety Communications have replaced Early Communications, Follow-Up Early Communications, Information for Healthcare Professional sheets, and Public Health Advisories. They are written in an easy-to-read, interactive format so that the public can access the information that is relevant to them. FDA has provided links on the new Drug Safety Communications page to the archived safety communications.

  

Early Communication About an Ongoing Safety Review: This type of communication is part of FDA's effort to communicate early with the public when the agency is still evaluating data and has not reached a conclusion. FDA shares information in the interest of informing doctors and patients about the issues that are under review and when FDA experts anticipate completing their review.