FDA Law Blog
OCTOBER 14, 2024
The District Court in this case, which came to the opposite conclusion and is now reversed, was a notable outlier in a string of cases in other circuits upholding FDA’s authority to regulate stem cell clinics on similar grounds as the Ninth Circuit did here. Stem Cell Clinic, LLC , 998 F.3d 588, 566 (2019)). 3d 1314 (D.C.
PEMBlog
SEPTEMBER 27, 2023
The diagnosis of a virus illness is generally made clinically with a history and clinical exam and does not require confirmatory testing. We understand many families request this test and we urge you to talk with them about these recommendations so we can move to reducing the number of clinical tests that will not change management.
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FDA Law Blog
JUNE 23, 2021
I have witnessed it inform whether clinical trial results are clinically meaningful (or not) as well as the selection and even development of primary endpoints. What Dr. Cavazzoni lays out is the traditional way in which patients have informed drug benefit-risk decision-making: by setting the “clinical context” of the disease.
PEMBlog
SEPTEMBER 24, 2024
Most patients are afebrile by the third day of treatment and clinically improved within two weeks. 2019 Apr 1;48(4):e169-e174. He initially presented to his pediatrician two months prior with 10 days of cough and unexplained fevers. References Palla J, Sockrider MM. Congenital Lung Malformations. Pediatr Ann.
Physician's Weekly
JUNE 22, 2025
They reviewed 4,033 patients at Mayo Clinic from June 1, 2019, to May 31, 2024, which encompassed demographic and clinical data. Urinary mast cell mediators, specifically 2,3-BPG, NMH, and LTE4, were quantified using liquid chromatography-tandem mass spectrometry and normalized to creatinine (Cr) levels.
Medical Xpress
JUNE 8, 2025
Long-term effects of pain in early life We collected data on the number of procedures, clinical exposures and sucrose doses from three NICUs across Canada. But as the findings from our Canadian study show, we urgently need research to improve long-term health outcomes for children born prematurely.
Physician's Weekly
JUNE 26, 2025
His clinical study was ending. In 2001, the CDC set up the Clinical Immunization Safety Assessment project, through which a network of eight U.S. A little-publicized CDC-led 2022 study suggested that the aluminum salts added to make some pediatric vaccines more effective might cumulatively be linked to an increased incidence of asthma.
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