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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. long-term nursing homes, clinics), highlighting their perceived needs. Family physicians' pivotal role in prevention and crisis management exposes them to mental stressors due to the highly demanding circumstances.

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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 It’s Tricky – FDA’s New Draft Guidance Provides Updated Recommendations on How to Best Use Data Monitoring Committees in Clinical Trials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Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring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. That checklist includes patient demographics and the individual patient’s clinical needs. Based in Bucks County, Pa.,

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

FDA Law Blog

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). Javitt & Allyson B.

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

FDA Law Blog

Regulating LDTs: A Long and Winding Road In what might sound to some like protesting too much, the PR invokes FDA’s longstanding assertion that IVDs “manufactured” by laboratories are medical devices and that clinical laboratories that develop tests are acting as manufacturers. FDA’s position is, however, only one side of the story.

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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

In an appendix, FDA provides a model “decision check list” for patients. 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.

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Documenting and honoring preferred place of death in oncology hospice patients [Palliative and end-of-life care]

Annals of Family Medicine

A US-based study conducted by the Kaiser Family Foundation found 69% of patients reported avoiding discussions about death, but 92% reported feeling somewhat comfortable talking to a heath care provider about EOL wishes. Setting or Dataset: Outpatient palliative care cancer clinic at a tertiary health care center in the U.S.

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