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Dedicated ICU management: Navigating the transition

Sound Physicians

Sound Critical Care is at the forefront of bringing coordinated leadership and clinical excellence to hospital ICUs and the patients within them. When we meet with hospitals who utilize a local pulmonology group about a critical care partnership, we aim to involve the local pulmonary practice early and deliberately when appropriate.

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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

address common questions and misconceptions about collecting and submitting to FDA patient engagement information regarding the design and conduct of a medical device clinical study.”. What would be the potential benefits if companies prospectively design medical device clinical studies with input from diverse patient advisors?

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CDRH Seeks Public Comment on How to Increase Patient Access to At-Home Use Medical Technologies

FDA Law

Cato — On June 1, CDRH announced that it is seeking public comment on questions regarding how CDRH can facilitate access to medical technologies designed for use outside of traditional clinical settings, particularly in the home. What medical technologies could be ideal to transition to use in non-clinical settings?

Medical 45
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A Final LDT Rule in April!? Will FDA be prepared?

FDA Law

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. 14] Thus, while the Third-Party Review Program is not well‑utilized generally, it is not utilized at all by the in vitro diagnostic industry. 31, 2023), [link]. [10]

IT 69
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The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments

FDA Law

The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries. based upon the anticipated clinical benefit of earlier patient access to the product.”. Notable Dates and Timelines – Applications open, Q4 of FY 2023.

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Lead, follow or get out of the way

Physician's Practice

Use whatever methods are available (articles, Webinars, videos, social media, podcasts, etc.) Neil Baum, MD , a Professor of Clinical Urology at Tulane University in New Orleans, LA. Form or be part of a focus group where you can ask questions and share concerns that will impact your judgment. Make an informed decision.