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On May 17, 2017, the Food and Drug Administration issued a safety recall for the Magellan Diagnostics' LeadCare Testing Systems due to the potential for inaccurately low blood lead test results when used with venous blood samples. Concurrently, the Centers for Disease Control and Prevention (CDC) issued a health alert with retesting recommendations for specific high-risk populations. The purpose of the CDC retesting recommendations was to help identify high-risk individuals so that those potentially impacted by falsely low test results could be retested and receive appropriate follow-up care. The CDC's Lead Poisoning Prevention Program sought to understand how the recall and recommendations impacted state and local public health agencies. Childhood lead poisoning prevention programs (CLPPPs) in state and local public health agencies collect blood lead test results for children and had a lead role in identifying children for retesting. Case studies are presented that highlight the experiences of 4 state CLPPPs in responding to the recall and recommendations. Collectively, the case studies point to several lessons learned, including the importance of (1) having a well-functioning surveillance system in place prior to a serious incident; (2) having a clear understanding of the roles partners play in the continuum of care for children potentially exposed to lead; and (3) ensuring effective communications with all staff, both internal and external, to public health agencies that have a role in responding to a serious incident. The ability to respond to public health emergencies or other serious incidents takes the combined effort of federal, state, and local public health agencies as well as others in the health care delivery system. The CDC will continue to support state and local lead poisoning prevention programs so that they have the information and tools they need to address and prevent the health effects of lead exposures in communities.

Investigator-initiated clinical trials represent a small but extremely important portion of medical research. In the process of translating basic science discoveries to novel therapies, new drugs or devices may be developed and tested. In light of increased compliance scrutiny, the need to streamline research projects, and the growing complexity of the U.S. Food and Drug Administration's (FDA's) regulations, the research leadership at the University of Minnesota Academic Health Center (AHC) determined in 2002 that a service should be established to address these issues. The assumption was that providing a service to assist researchers with regulatory obligations would result in additional clinical research that might not have been pursued due to perceived regulatory hurdles. The authors present an overview of the FDA regulatory process as it applies to investigator-initiated research involving investigational new drugs and investigational medical devices. The rationale for creating a program designed specifically to assist faculty with investigational new drug (IND) applications and investigational device exemption (IDE) applications is discussed. The services provided by the IND/IDE Assistance Program (IAP) at the University of Minnesota Academic Health Center are described. The value of the IAP to the AHC is presented along with examples of successes attributable to the IAP and lessons learned so far. Since the establishment of the IAP several issues that might have placed the university at risk have been identified. These issues have been addressed to help improve the ease in which investigator-initiated research is conducted and compliance is maintained.