The US Food and Drug Administration (FDA) on October 29 released a report describing the agency's ongoing efforts to improve its regulatory policies for personalized medicine. The report, titled Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development, falls short of outlining any new regulatory pathways but does offer a resource to help companies with such products in development to navigate the FDA. From 2009, when the agency created a personalized medicine staff within the device center's Office of In Vitro Diagnostics and Radiological Health, it has been intensifying its commitment to the field. In 2011, the agency's biologics center created a personalized medicine team. The recent report lists 22 guidance documents related to personalized medicine and numerous organizational changes at the agency to streamline regulatory oversight. But challenges remain. Coordinating regulatory oversight of therapeutics and their companion diagnostics requires expertise from multiple FDA centers. The process is complicated, and the agency stressed in the report that companies should communicate with the FDA early and frequently. “The biggest take-home message from this report is: When you are putting your program together for your company, you need to get in touch with the FDA and start a dialog,” says Philip Arlen, CEO at Precision Biologics in Rockville, Maryland. “They are saying, 'Engage us'.”