FDA Talks Up Continuous Manufacturing, Offers Assistance
It is time for drug makers to embrace continuous manufacturing methods, CDER Director Janet Woodcock and other FDA officials emphasize. Now the agency is offering additional support to help manufacturers move away from batch processes.
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All-out efforts by agency staff to help industry supply COVID-19 treatments last year were applauded but now its attention returns to the top pre-pandemic priority, contamination risks. Edge Pharma consents to attack mold, Glicerinas blocked over inspection refusal, Bioiberica hit for ‘reprocessing’ contaminated drug substance, Rentschler bashed for inadequate monitoring.