FDA Law Blog
MARCH 4, 2024
Early notification can play a role in decreasing the impact and duration of such supply disruptions and product shortages. blood supply; and, Manufacturers of certain finished drug products marketed without an approved NDA or ANDA.
FDA Law Blog
MARCH 1, 2023
In this report, it’s stated that 62% of drug shortages reported between 2012 and 2017 were due to quality issues which is attributed in part to a lack of recognition or reward for manufacturers with mature quality management systems that focus on continuous improvement and early detection of supply chain issues.
FDA Law Blog
APRIL 8, 2024
Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response.
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