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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 It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials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. They also both stressed the value of previous DMC experience.

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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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FDA Phones a Friend: Joint Statement with CMS Eschews CLIA Modernization and Supports FDA Oversight of LDTs

FDA Law

Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs). Gonzalez & Gail H.

Clinic 59
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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.

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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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Kaiser Permanente study shows screening efforts cut colorectal cancer deaths in half

Permanente Medicine

million men and women aged 50 to 75 examined the outcomes of a Kaiser Permanente Northern California initiative begun in 2006 to increase colorectal cancer screening rates. Levin, MD , a Kaiser Permanente Division of Research scientist and gastroenterologist with The Permanente Medical Group. The study of 1.1