FDA Pulls Off-Label Warning Letter – Can It Delete Pacira's Lawsuit Too?
This article was originally published in The Pink Sheet Daily
Agency may be trying to limit scope of eventual ruling in Free Speech court case focusing on interpretation of labeling.
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The International Medical Device Regulators Forum, perhaps most notorious for its efforts to standardize audit processes between nations with its Medical Device Single Audit Program, is also focusing on harmonizing device reviews and adverse event codes.
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.
Device center officials at the US agency focused on new approval pathways at RAPS Convergence 2020.