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A Mixed Studies Literature Review on Mental Health Perceived Needs of Family Physicians in Infectious Catastrophes [Education and training]

Annals of Family Medicine

This can potentially compromise their ability to provide optimal patient care. ’s (2006) framework. Employing thematic analysis, seven distinct themes emerged, which were then classified across four overarching levels: societal, institutional, organizational, and individual.

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 It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials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

Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring Committees” and, when final, will replace the 2006 guidance.

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How hospitals can cut admission delays by 30%

Today's Hospitalist

Those interventions included standardizing both bed assignments and nursing handoffs while having ED providers—not an inpatient team—enter skeletal orders when deciding to admit a patient. Such delays can compromise patient care by increasing mortality, medical errors and length of stay.

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

FDA Law Blog

Shapiro — Last summer, FDA published a draft guidance, Laser-Assisted In Situ Keratomileusis (LASIK) Lasers – Patient Labeling Recommendations (July 29, 2022) setting forth a proposal for new recommended patient‑directed labeling. The approved devices already have patient‑directed labeling that FDA has approved. By Jeffrey K.

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

FDA Law Blog

The PR first sets out to establish that it has authority to regulate in vitro diagnostic “test systems” as devices, and not just the system’s individual components, such as reagents, instruments, specimen collection devices, and software.

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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. Today we are talking about the patient care experience specifically here at Kaiser Permanente, but also in general. I joined SCPMG straight from residency in 2006. AM: Thank you so much.

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FDA to Require Breast Density Notification Amongst Other Updates to Mammography Regulations

FDA Law Blog

The MQSA was passed to ensure, among other things, that nationwide, patients have access to quality mammography services. See Government Accountability Office, “ GAO-06-724 Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations ” (July 2006). Your breast tissue is not dense.