Hyman, Phelps & McNamara withdraws a petition to FDA that sought to delay the posting of an unnamed client’s Warning Letter until an appeal had been exhausted and requested redactions were made.
Federal Register Notice: FDA releases the document, “Specifications for File Format Types Using eCTD Specification,” to support electronic format regulatory submissions.
Public Citizen asks FDA to withdraw its proposal to reclassify automated external cardiac compression devices, while Laerdal Medical voices support for the change.
Abbott recalls its FreeStyle InsuLinx Blood Glucose Meters due to potential blood glucose display errors when extremely high blood glucose test results are measured.