US FDA Races To List Essential Medicines For Domestic Manufacture By White House Deadline
With list due 4 November, there may not be time for public comment. Meanwhile, where will biopharma find fill/finish capacity?
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The Trump administration’s move to strengthen domestic manufacture of essential medicines raises a lot of questions – and industry’s ire.
Under pressure to authorize use of Lilly’s bamlanivimab, the FDA must first weigh efficacy signals and GMP plant remediation progress.
“Any practices that limit the social interaction between the investigator and the firm are always good,” says FDA ORA official Rachel Harrington. Donald Ertel, of FDA’s Center for Biologics Evaluation and Research, encourages firms to “try to maintain a one-way flow through the facility” for investigator plant walkthroughs.