The first act of Congress giving the FDA authority to regulate medical devices was in 1976, in response to the sale of unsafe intra-uterine devices, or IUDs, to thousands of American women. Since 1987, all clinical software - from programs that maintain patient and accounting records to those...
The FDA does not regulate CME but ... it does regulate promotion, and often the line between what it considers scientific education and industry-sponsored promotion is fuzzy. (Food and Drug Administration; continuing medical education; pharmaceutical industry)(includes related article)...
As with other kinds of drugs, FDA regulates the quality & safety of gene therapy products and supervises how these products are used clinically.; Therapeutic alteration of the human genome falls under the same regulatory requirements as any other medical treatment. Research involving human subjects,...
Does the FDA Have Authority to Regulate Human CloningElizabeth Price Foley
“a single phytoconstituent that could be used in the treatment of (diabetes and obesity) would be a welcome addition. Gymnemic acid fulfills this criterion” In this study the group confirmed that this ingredient could be used positively to help regulate body weight and blood sugar. ...
They regulate everything from your metabolism and energy levels to your skin’s texture and your hair’s strength and shine. Among these hormones, testosterone takes center stage, especially when it comes to defining and enhancing your natural beauty. The Role of Testosterone Testosterone, often ...
Also, beware of over-the-counter weight loss products.The U.S. FDA does regulatedietary supplements. But it treats them like foods rather than medications. The FDA also doesn't regulate claims made by over-the-counter weight loss products. Unlike drug manufacturers, the makers of supplements ...
Emergency use authorization allows for the availability and employment of medical countermeasures such as vaccines during public health emergencies like the COVID-19 pandemic. Further FDA evaluations may lead to the full approval of such treatment, as in the case with the Pfizer vaccine. ...
The increase in the frequency and intensity of droughts is pointed out as one of the main factors altering biogeochemical cycles in the Amazon basin. An eco-nutritional approach using X-ray fluorescence micro-analysis (µXRF) is proposed to verify the long- and short-term effects of droughts...
Extracorporeal photopheresis (ECP) is an FDA-approved immunotherapy for cutaneous T-cell lymphoma, which can provide a complete response in some patients. However, it is still being determined who will respond well, and predictive biomarkers are urgently needed to target patients for timely treatment...