Industry Fears Report-Writing Burden From Supply Chain Risk Guidance US FDA Is Drafting
As agency prepares guidance on CARES Act requirement for risk management plans to help prevent shortages of critical medicines, industry raised concerns that a broad interpretation of the “life-saving drugs” term used in the legislation could make compliance challenging.
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As the response to another wave of COVID-19 infections continues, fill rates of critical medicines such as methylprednisolone are dropping. But experts say the answer is not to concentrate manufacturing in US facilities, which could lead to further risks if US supply is disrupted.
Monthly data are expected in annual reports on listed drugs and active ingredients from every registered site, starting in February.
Extension will add training materials with goal of reducing quality defects and recalls. Revision process will also address shortage indicators related to production failures in an attempt to head off drug shortages.