Enbrel, Prolia Suffer FDA’s Combination Punch On Device Components
This article was originally published in The Pink Sheet Daily
Amgen did not follow proper procedures when it switched from one Enbrel vial adapter to another, FDA says, a change that led to an uptick in product complaints.
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Neither has announced a firm timeline, and the difference between Pfizer's 'October' and Moderna's 'November' could be mere hours or a few weeks, but Pfizer, by dint of luck or experience, is now in a position to offer the more optimistic projection on when it will seek an EUA. Both firms release their Phase III trial protocols, which seem in line with US FDA guidance.