Health Care Law News and Insights

Introduction The Prescription Drug User Fee Act of 2017 (PDUFA VI) authorizes the U.S. Food and Drug Administration (FDA) to assess fees (PDUFA fees) when applicants submit new drug applications (NDAs). PDUFA fees are substantial. For example, the PDUFA fee for an NDA requiring clinical data will be $2,942,965 in 2020....

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The Eleventh Circuit’s recent decision in United States v. Aseracare, Inc., No. 16-13004 (11th Cir. Sept. 9, 2019) makes clear that reasonable minds can disagree in the exercise of clinical judgment without constituting actionable fraud in medical certifications for reimbursement by Medicare. The False Claims Act (FCA) allows the state and...

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The Sixth Circuit activity continues to escalate as the MDL bellwether trial date approaches. In just the last week, since the Court of Appeals’ rare order requesting a response to Ohio's mandamus petition, we've seen: Judge Polster respond—energetically—to Ohio's mandamus petition, one day sooner than the deadline provided in the Court of Appeal's order;...

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