FDA has selected CFS/ME as the first topic for the PDUFA V patient-centered drug development initiative. The lessons learned from this session will inform future work on patient engagement in drug development both for FDA—and for patient advocates.

December’s Arthritis Advisory Committee review of Hemispherx’s drug provided FDA with the first public opportunity to explain in detail why the chronic fatigue syndrome drug, in development for almost 25 years, has not passed regulatory muster to date.

Division of Mitigation Assessment and Medication Error Surveillance will be established within the Office of Surveillance and Epidemiology, a change aimed at strengthening postmarketing oversight of opioids and other drugs; new Office of Safety and Clinical Evaluation will be created in Office of Generic Drugs, where Orange Book staff also will get their own division.