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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. Why the gap?

IT 52
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OTAT Town Hall on Cell Therapy CMC – The Recording is Available but Here’s an Appetizer

FDA Law Blog

The purpose of these town halls are to discuss topics related to OTAT-regulated products, engage with product development stakeholders, and to provide information to help stakeholders to help advance drug development. In case you do not have time to watch the town hall , we provided a summary of select topics that are discussed below.

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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. The guidance provides no rationale for hinging the device status of CDS software on the frequency with which medical information is collected.

Clinic 52
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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.