Sen. Alexander And The Terrible, Horrible, No Good, Very Bad Reg
This article was originally published in The Pink Sheet Daily
FDA’s proposed rule to allow generic manufacturers to unilaterally change their labels should be scrapped in favor of congressional action, a group of 28 Republican senators and representatives tells the agency.
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FDA proposed rule would allow ANDA holders to unilaterally make label changes prior to FDA’s approval; NDA and other ANDA holders would have 30 days to revise their labels once FDA approves the change.
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.
Agency directs Sprout to disseminate corrective messages about the risks associated with the female sexual dysfunction pill. Sprout previously challenged FDA’s alcohol labeling requirements.