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US FDA Races To List Essential Medicines For Domestic Manufacture By White House Deadline

 
• By Bowman Cox

With list due 4 November, there may not be time for public comment. Meanwhile, where will biopharma find fill/finish capacity?

Female athletes running towards finish line on track field
another race that ends in november

The executive order for the US government to buy American-made essential medicines that president Trump signed 6 August has stirred a rush of activity in the US Food and Drug Administration to decide which medicines are essential, Douglas Throckmorton, deputy director for regulatory programs in the agency’s Center for Drug Evaluation and Research, told the recent Parenteral Drug Association/FDA meeting.

Executive Order 13944, signed by president Trump on 6 August and published in the Federal Register on 14 August, gave FDA commissioner Stephen Hahn 90 days to establish an initial list of essential medicines, in consultation with several White House and Health and Human Services Department officials

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