article thumbnail

Ninth Circuit Upholds FDA’s Authority to Regulate Stem Cell Clinic Treatments

FDA Law Blog

These procedures are offered to treat a variety of conditions, including Alzheimer’s, arthritis, asthma, cancer, etc., The lowest risk category, which is not subject to any oversight by FDA, includes HCT/Ps removed from an individual that are implanted into the same individual during the “same surgical procedure.” 21 U.S.C. §

Clinic 59
article thumbnail

Critics Suggest FDA Approving Aduhelm Will Erode the “Public Trust”: What About Patients’ Trust?

FDA Law Blog

For example, we know that cancer patients have a high tolerance for toxicity when offered a chance at improved survival, a risk tolerance that would not be shared by individuals suffering from the common cold. Instead, the ultimate clinical benefit must be confirmed in a post-approval study. By Asking Them. 18, 2018).

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Gender Influences Urinary Mast Cell Biomarkers

Physician's Weekly

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.

Asthma 52
article thumbnail

Preemies receive sucrose for pain relief—new research shows it doesn't stop long-term impacts on development

Medical Xpress

However, we do not guarantee individual replies due to the high volume of messages. Your feedback is important to us. E-mail the story Preemies receive sucrose for pain relief—new research shows it doesnt stop long-term impacts on development Your friends email Your email I would like to subscribe to Science X Newsletter.

IT 53
article thumbnail

Analysis of primary care prescription trends in England during the COVID-19 pandemic compared against a predictive model

BMJ

We used the first six years of the dataset to form a predictive model using Holt-Winters forecasting (a time series predictive method based on trends and seasonality), and then compared the observed data from November 2019 to November 2020 with the model to assess the impact of the COVID-19 pandemic on prescribing.