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 It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials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

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.

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. One VA center reduced its admission delay by almost one-third with a series of three interventions. Such delays can compromise patient care by increasing mortality, medical errors and length of stay.

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

FDA Law Blog

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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What every physician should know about care experience (and why it matters)

Permanente Medicine

They candidly discuss the unique challenges and opportunities health care organizations face in meeting patient expectations. Assistant Regional Medical Director, Care Experience Southern California Permanente Medical Group Podcast transcript Transcript is autogenerated. I joined SCPMG straight from residency in 2006.

IT 52
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Gabapentinoids – Gabapentin and Pregabalin: Tasce Bongiovanni, Donovan Maust and Nisha Iyer

GeriPal

The FDA-approved indications for gabapentin are only for treating patients with partial seizures or postherpetic neuralgia. valproic acid and gabapentin), in nursing homes, particularly patients with Alzheimer’s disease and related dementias. 2006 Transcript Eric: Welcome to the GeriPal Podcast. Annals of IM. Tasce: Yes.

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How State and Local Agencies on Aging Help Older Adults: Susan DeMarois, Greg Olsen, and Lindsey Yourman

GeriPal

Started as a direct case manager, worked in a variety of different places including the state legislature and I’ve been with the state office now since 2006. It was designed to really balance what Medicaid at the time was to provide nursing homes and Medicare is obviously health insurance. Eric: And Susan?

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Guiding an Improved Dementia Experience (GUIDE) Model: A Podcast with Malaz Boustani and Diane Ty

GeriPal

Don’t get me wrong, the evidence points to cost savings, but as Chris Callahan and Kathleen Unroe pointed out in a JAGS editorial in 2020 “in comprehensive dementia care models, savings may accrue to Medicare, but the expenses accrue to a fluid and unstable network of local service providers, patients, and their families.”