Newly Aligned Teams Sped US FDA’s Drug Quality Reviews Over Pandemic Hurdles
Realignment played key role in keeping assessments on track as COVID-19 buckled pharmaceutical supply and distribution chains and prevented inspections.
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US FDA excludes chronic care products from list of medicines bolstered by domestic production investment and federal procurement requirements.
The Trump administration’s move to strengthen domestic manufacture of essential medicines raises a lot of questions – and industry’s ire.
Remediation must be quick and sure, say FDA’s Woodcock and Marks, despite challenges with facilities, equipment, processes and personnel training.