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Beware the bait-and-switch when it comes to HM program contracts

Sound Physicians

Other medical groups may, over the course of your contract, increase physician compensation at intervals, increase program management fees, and put risk back on you when it comes to retention, turnover, quality metrics, and revenue projections. We know how to manage temp labor costs with internal resources. percent and 5.7

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The Incredible Shrinking Exemption: FDA Final CDS Guidance Would Significantly Narrow the Scope of Exempt Clinical Decision Support Software Under the Cures Act

FDA Law Blog

The final guidance therefore may have significant implications for a wide range of stakeholders, including not only software developers but also health care providers, hospitals, patients and payors. Criterion 2 : Non-Device CDS software functions display, analyze or print medical information about a patient or other medical information.

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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog

As you may know, there are challenges related to developing potency assay(s), and the Alliance for Regenerative Medicine and the American Society of Gene and Cell Therapy recently published a white paper on a workshop held to discuss these challenges. The workshop is also discussed in Cell & Gene here and here.

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Does the Drug Shortage White Paper Fall Short?

FDA Law Blog

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response. By Kalie E.