It appears more likely that the federal government, including FDA, will face a 10/1 shutdown due to a Congressional impasse to approve an appropriations bill for fiscal year 2024.
FDA releases a two-item Form FDA-483 citing GMP issues documented at Novo Nordisk’s Clayton, NC facility during a 7/6-13 inspection.
It appears more likely that the federal government, including FDA, will face a 10/1 shutdown due to a Congressional impasse to approve an appropriations bill for fiscal year 2024.
FDA releases a two-item Form FDA-483 citing GMP issues documented at Novo Nordisk’s Clayton, NC facility during a 7/6-13 inspection.
U.S. Senator Dick Durbin (D-IL) and Representative Jan Schakowsky (D-IL) introduce bicameral legislation to improve the medical device recall process.
FDA’s Endocrinologic and Metabolic Drugs Advisory Committee votes 19 to 0 against approving Intarcia Therapeutics’ implantable ITCA 650 (exenatide in DUROS device), indicated for improving glycemic control in adults with Type 2 diabetes.
