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Vaccine Uptake Strategies & Ethical Considerations- Part II

Integrated Care News by CFHA

Availability and Requirements Vaccination programs in communities, including schools, childcare centers, community gathering places, and homes, also successfully improve vaccine uptake, especially for children less likely to access healthcare. I discussed this debate in my previous blog post.

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4 Ways Temporary Medical Staff Maintain Patient Care

Barton Associates

In this blog, we’re going to outline four key ways temporary medical staff such as locum tenens providers can help healthcare facilities maintain continuity of high-quality patient care in the face of growing shortages. These professionals play a vital role in maintaining essential services and ensuring continuity of patient care.

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How to Run DMC? It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials

FDA Law Blog

The new draft guidance is generally reflective of these developments, and we wanted to highlight several of the changes in this blog post. DMC charters have also grown longer and more detailed.

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Wearables, Sensors, and Apps Part 1 – Updates on FDA’s PDUFA VII Goals for the Use of Digital Health Technologies in Drug and Biological Product Development

FDA Law Blog

This blog provides an update on the DHT-related PDUFA VII goals that were targeted for completion in the first two quarters of FDA’s Fiscal Year (FY) 2023, including: By the end of Q2 FY 2023, FDA will establish a DHT framework document to guide the use of DHT-derived data in regulatory decision-makings for drugs and biological products.

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Could the Road to an AKS Violation Be Paved with Good Intentions? Pfizer Asks SCOTUS

FDA Law Blog

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R. Pfizer’s Petition to SCOTUS. SCOTUS has until Dec.

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Let’s Listen to Patients: FDA Releases Final Guidance on Patient Engagement in the Design and Conduct of Medical Device Clinical Studies

FDA Law Blog

Bauer, Senior Regulatory Drug Expert — Our readers probably know that we value and advocate for patient engagement as an essential component in the development of medical products (see our firm’s commitment here ).

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CMS Proposes Rule to Implement Mandatory Medicare Part B Discarded Drug Rebates

FDA Law Blog

Kirschenbaum — Last November, we blogged about a provision of the Infrastructure Investment and Jobs Act that requires new rebates for discarded amounts of drugs that are covered under Medicare Part B, and that are packaged in a single-dose container or single-use package.