Industry Fears Report-Writing Burden From Supply Chain Risk Guidance US FDA Is Drafting
Executive Summary
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.
You may also be interested in...
Reshoring Debate Continues As COVID-19 Drives New Wave Of US Drug Shortages
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.
How US FDA Wants Pharmaceutical Production Volumes Reported For Drug Shortage Prevention
Monthly data are expected in annual reports on listed drugs and active ingredients from every registered site, starting in February.
ICH Q9 Revision Delayed By Three Months Due To COVID; Focus Spans Risk Assessments, Shortages
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.