2006 Clinic Individual IT 
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Clissold — The trio of CDER, CBER, and CDRH released a new draft guidance titled “ Use of Data Monitoring Committees in Clinical Trials ” that revises the 2006 guidance “Establishment and Operation of Clinical Trial Data Monitoring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
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.
Today's Hospitalist
JUNE 7, 2025
They presented a rapid clinical update Webinar in May 2025 hosted by the Society of Hospital Medicine. ” All anti-obesity medications, even the earlier generation of these drugs—which include orlistat, phentermine, phentermine/topiramate (Qsymia) and naltrexone/bupropion (Contrave)—cause clinically significant weight loss.
GeriPal
MARCH 2, 2023
2006 Transcript Eric: Welcome to the GeriPal Podcast. By 2015 that number increased to 4% of US adults. There are a lot of reasons that may explain the massive increase in use of these drugs. One thing is clear, it is not because people are using it for FDA approved indications. Cochrane Database of Systematic Reviews Review. Annals of IM.
FDA Law Blog
MARCH 15, 2023
See Government Accountability Office, “ GAO-06-724 Mammography: Current Nationwide Capacity Is Adequate, but Access Problems May Exist in Certain Locations ” (July 2006). Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.” Your breast tissue is not dense.
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