US FDA Races To List Essential Medicines For Domestic Manufacture By White House Deadline
Executive Summary
With list due 4 November, there may not be time for public comment. Meanwhile, where will biopharma find fill/finish capacity?
You may also be interested in...
Initial List Of US Essential Medicines Focuses On Acute Care
US FDA excludes chronic care products from list of medicines bolstered by domestic production investment and federal procurement requirements.
Can 'Buy American’ Executive Order Shake Up ‘Dickensian’ Manufacturing Dynamics?
The Trump administration’s move to strengthen domestic manufacture of essential medicines raises a lot of questions – and industry’s ire.
US FDA Would Allow Separation Alternatives In Manufacture Of Low-Risk Beta-Lactams
Proposed guidance revision adds nuance to manufacturing facility separation expectations for beta-lactam compounds that pose less risk of anaphylaxis than penicillin and related antibiotics.