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 It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials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

Tobolowsky & Véronique Li, Senior Medical Device Regulation Expert & David B. Moreover, DMCs are being used in trials of modest size and in the context of increased globalization of medical product development. DMC charters have also grown longer and more detailed.

Clinic 105
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How hospitals can cut admission delays by 30%

Today's Hospitalist

Key takeaways: Admission delays from the ED can adversely affect mortality, length of stay, medical errors and quality of care. Such delays can compromise patient care by increasing mortality, medical errors and length of stay. ” Nathan Baskin, MD San Francisco VA Medical Center And they succeeded. reduction. .”

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Gastroenterology Board Meeting Summary | Spring 2025

ABIM

While some expressed approval for the recent enhancements to the LKA, others inquired whether ABIM would consider instituting a break or “year off” between five-year cycles and questioned how ABIM ensures the relevance of assessment questions to highly specialized clinical practice. Applications are due July 20, 2025.

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A Question 30 Years in the Making: Would a Final LDT Rule Withstand Judicial Scrutiny?

FDA Law

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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Draft LASIK Guidance: Why Did FDA Issue New Labeling Recommendations for Products that Already Have PMA Approved Labeling?

FDA Law

This form lists important risks, including those known or reported to be associated with the use of the LASIK laser devices based on information from clinical trials, scientific literature, and reports from patients who have undergone LASIK. After reviewing the information. Regulatory Analysis. In this context, this statement is absurd.

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How to manage GLP-1s in the hospital

Today's Hospitalist

Because many medications can cause weight gain, doctors should consider more weight-neutral alternatives. Medical societies and hospitals are weighing in on periprocedural concerns in patients taking GLP-1s who need procedures or surgeries. Key takeaways: Hospitalists will increasingly have to manage inpatients taking GLP-1s.

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Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

2006 Transcript Eric: Welcome to the GeriPal Podcast. It’s not a controlled substance medication. Eric: So I heard gabapentin is the 10th most commonly prescribed medication in the US. I also heard that if you look at all individuals in the US, about 4% of individuals are taking one of the gabapentinoids, 10% over 65.