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.

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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.

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Physician's Weekly

JUNE 22, 2025

Males had higher levels of urinary mast cell mediators—LTE4, 2,3-BPG, and tryptase—particularly in atopic individuals, compared to females. These sex-based differences suggest the need to account for sex in interpreting diagnostic biomarkers for mast cell and atopic disorders.

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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. However, we do not guarantee individual replies due to the high volume of messages. One of these sites does not use sucrose for acute pain management.

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