Opioid Packaging: Is Non-Inferiority Enough For A New Claim?
Industry exec suggests new packages need be merely no worse than the classic amber vial to gain a claim, but US FDA says packaging intended to fight abuse should be better.
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US FDA commissioner nominee could face a slew of questions about non-drug issues such as e-cigarette regulation, which may mean pharma must read between the lines for insight into his drug-related policy stances.
In his first speech to an outside group, Sharpless strikes a collaborative tone, saying he expects to listen to the advice of the FDA bar, as well as his own experts.
The agency requested a funding increase in part to implement 2018 legislation intended to combat the opioid crisis, but also to support many initiatives in last year's budget request.