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Dedicated ICU management: Navigating the transition

Sound Physicians

For hospitals, this means investing in cutting-edge medical interventions and partnerships that help them transition to the modern best-practice of dedicated ICU management. For smaller or rural hospitals, this can mean supplementing patient care with tele-ICU clinicians, available 24/7, to keep our providers from stretching too thin.

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A Final LDT Rule in April!? Will FDA be prepared?

FDA Law Blog

Unless FDA provides timely responses to pre-submissions, laboratories (and current IVD manufacturers) will not be able to submit applications that address FDA’s expectations. During the October 31, 2023 webinar discussing the proposed rule, stakeholders sought clarity from FDA officials on the Agency’s plan to address the resource gap.

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Lead, follow or get out of the way

Physician's Practice

This can also happen in a reverse scenario where the practice must turn to outsourcing as their backup plan because their staff is unqualified to manage an in-house billing program.) Focus on providing optimum patient care and financial success will follow Rules are made for a reason and should be followed.

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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law Blog

FDA will discuss the goals letter and field public comments, on September 28, 2021 (announcement here ), as well as a separate workshop on meetings management practices, which is to be held by July 30, 2024. Pandemic influences aside, the FY 2023-2027 goals letter contained many notable new initiatives, announcements, and commitments.