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Drug & Device News
Seizure Drug Labels Warn of New Dangers
In a letter sent April 18, Novartis Pharmaceuticals and the Food and Drug Administration (FDA) notified health care professionals about revisions to the “Warnings” and “Precautions” sections of the prescribing information for Trileptal'(oxcarbazepine) tablets and oral suspension. Trileptal is used for treatment of partial seizures in adults and children ages 4-16 years with epilepsy. The updated “Warnings” section describes serious dermatological reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), that have been reported in both children and adults in association with Trileptal use. The “Precautions” section was updated to warn of multi-organ hypersensitivity reactions that some users of Trileptal have reported experiencing.
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The DOJ's Corporate Enforcement Policy: One Year Later
The DOJ's Criminal Division issued three declinations since the issuance of the revised CEP a year ago. Review of these cases gives insight into DOJ's implementation of the new policy in practice.
How AI Has Affected PR
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The DOJ's New Parameters for Evaluating Corporate Compliance Programs
The parameters set forth in the DOJ's memorandum have implications not only for the government's evaluation of compliance programs in the context of criminal charging decisions, but also for how defense counsel structure their conference-room advocacy seeking declinations or lesser sanctions in both criminal and civil investigations.