US Enforcement 2019: Compounding, Opioids Top Priorities But Beware Of REMS Violations, Too
Drug manufacturer reimbursement support services also are garnering a growing amount of enforcement attention, and misleading promotion - whether on- or off-label - remains on the radar of government investigators.
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US FDA says opioid and opioid use disorder treatment labels should suggest providers discuss naloxone availability with patients and caregivers and consider co-prescribing to patients at high-risk of overdose, but it does not mandate co-prescribing, the most aggressive (and costly) option that had been considered.
Yell It From The Rooftops: Hep C Drug Safety Notice Another Example Of FDA's Limited Power Over Prescribers
After its bully pulpit, the US FDA's options to encourage physicians to follow labeling recommendations for hepatitis C drugs are limited.
Vaccination policies could result in arguments over states' rights instead of public health concerns, outgoing US FDA commissioner warns.