FDA Law Blog
MARCH 7, 2024
Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring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.
Today's Hospitalist
APRIL 24, 2025
That checklist includes patient demographics and the individual patient’s clinical needs. 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. reduction.
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FDA Law Blog
FEBRUARY 4, 2024
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).
PEMBlog
OCTOBER 26, 2023
“Clinically, Meckel diverticulum should be suspected in any child younger than 2 years of age with painless rectal bleeding. STAT Pearls, 2023 Wrap Up Meckel diverticulum is a congenital anomaly of the small intestine that can present with various clinical manifestations, including rectal bleeding and obstruction. ” An et.
FDA Law Blog
NOVEMBER 1, 2023
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 Law Blog
DECEMBER 12, 2022
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. This proposal is not, however, simply advice for preparation of an application for a new device.
Annals of Family Medicine
NOVEMBER 20, 2024
A 2006 study conducted at Marie Curie Hospice Edinburgh found 29% of 164 patients in hospice did not have a documented preferred place of death, indicating room for improvement in documenting this important EOL wish. Setting or Dataset: Outpatient palliative care cancer clinic at a tertiary health care center in the U.S.
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