Combating Drug Diversion and Counterfeiting in a Post-Serialization Landscape

FDA’s Division of Drug Information in the Center for Drug Evaluation and Research (CDER) is excited to present a series of educational webinars.

Over the past few years, the gastroenterology diagnostic market has witnessed an increase in commercial multiplex diagnostic assays for the detection of a large array of enteric pathogens. These multiplex assays differ in many aspects, one important difference being the number of enteric pathogens that the assays detect. Updated IDSA/SHEA guidelines for the management of infectious diarrhea describe a targeted approach, directing proper test utilization for the diagnosis of infectious diarrhea. The guidelines can assist with the development of targeted testing algorithms to diagnose the enteric pathogens most likely causing disease. This patient-centric targeted testing approach can be supported by using the BD MAX ™ system, which uses separate testing panels for the detection of C. difficile, bacterial, parasitic, and viral pathogens.

This session will discuss current changes in the laboratory testing marketplace and the impact on healthcare. Major trends will be discussed specific to physician practice, reimbursement, government programs, and patient care. Opportunities for clinical laboratories and pathology groups to add value for patients, physicians, payers, and hospitals will be examined. Discuss the basic forces for change present in the national marketplace for clinical laboratory and anatomic pathology testing. Explain the ways basic forces may disrupt existing relationships between laboratories and providers. Highlight management approaches to enable clinical laboratories to deliver high-value testing services to integrated healthcare organizations.

Now in its second year, this online symposium will provide those working within academia and pharmaceutical development the opportunity to hear from experts within the field.