Aegerion Juxtapid Settlement Shows REMS Have Teeth: Alternate Route To Enforce Off-Label?
Who says FDA can’t bring off-label cases? They may just morph into REMS violation cases – if, that is, FDA starts using the REMS authority more often.
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US Enforcement 2019: Compounding, Opioids Top Priorities But Beware Of REMS Violations, Too
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Gilead Asks Supreme Court To Restrict False Claims Act Cases
Complaints should not be allowed to go forward if government knew of regulatory infraction but continued to pay for drug, Gilead argues, asking US high court to 'finish task' of its Escobar ruling.
Copay Kickback Enforcement Gains Momentum: United Therapeutics Settles Charges
Settlement is first involving a copay assistance program operated through Caring Voice Coalition since the HHS Office of Inspector General rescinded a safe harbor for the charity's activities in late November. Is it the first of a wave?