Public health advisory issued on NeutroSpec
The FDA has issued a public health advisory to alert healthcare professionals that the agency has requested the market withdrawal of the diagnostic imaging agent NeutroSpec (technetium [99m Tc] fanolesomab) pending review of reported deaths and serious and life-threatening adverse events associated with use of the product. The manufacturer, Palatin Technologies, and marketing partner, Mallinckrodt, have agreed to implement voluntary market suspension, making the product unavailable for approved or investigational uses. NeutroSpec is a diagnostic imaging agent that is administered intravenously to help diagnose appendicitis in patients aged five years and older with possible appendicitis who lack its conventional signs and symptoms.
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
