Posts Tagged ‘FDA’

FDA is working hard to push drug companies to get more diversity into the clinical trials that are the foundation for bringing new, safe, and effective drugs into the market. In June, the agency issued guidance for diversity action plans to improve the representation of marginalized populations. But unfortunately, it has nothing to say about […]

A new study this week gives us pause for concern about the chemicals entering our body from food packaging. Some of them are endocrine disrupting chemicals that can alter the way our body stores fat. Researchers inventoried a total of 14,000 chemicals in contact with food from packaging and found evidence for 3,601 of them […]

The American College of Clinical Pharmacology is meeting in Bethesda this week. On the opening day, ACCP convened a symposium to address critical questions about how drugs work in people with obesity. What can we – industry, FDA, and scientists – do better? Because all too often, drug labels to guide safe prescribing are effectively […]

A gray market for obesity medicines is thriving. The quality of the products in this market range from reasonable to sketchy to utterly unreliable. But millions of people are taking a chance on them. Big pharma companies innovated to bring fully vetted formulations of important medicines to market, spending billions of dollars to do it. […]

The Nutrition Facts label, that black and white information box found on nearly every packaged food product in the U.S. since 1994, has recently become an icon for consumer transparency. From Apple’s “Privacy Nutrition Labels” that disclose how smartphone apps handle user data, to a “Garment Facts” label that standardizes ethical disclosures on clothing, policy […]

Looking for some naturally fast food? Minimally processed, but exquisitely prepared? Delicious, but not hyper-palatable? The U.S. Food and Drug Administration would like to help. According to Stat News, the agency is looking hard for ways to regulate ultra-processed food. It leaves us wondering if ultra-processed food can cause people to lose their minds. It […]

A new study presented at the American Diabetes Association Scientific Sessions this weekend shows us quite clearly that bisphenol A (BPA) causes insulin resistance. So we scratch our heads and wonder. Why do we keep on drinking it? This is no trivial observational study of correlations that would be easy to dismiss. Rather, it is […]

At a hearing this week fo the U.S. House Committee on Energy and Commerce, Representative Robin Kelly asked the Director of the FDA Center for Drug Evaluation and Research, Patrizia Cavazzoni, what the agency is doing to ensure that drug labeling adequately protects the safety of people with obesity: “Patients with obesity are frequently excluded […]

Firsts are worth celebrating. In this case, the cause for celebration is especially great. MASH or metabolic steatohepatitis is a disease that is growing dramatically more common and more harmful to the health of the population. Late this week, FDA approved resmetirom to be the first ever treatment for MASH with fibrosis. Note that the […]

It’s official. FDA now says that semaglutide, in doses used to treat obesity, can prevent heart attacks, strokes, and deaths in persons with cardiovascular disease and overweight or obesity. This is nothing short of the dawn of a new era in obesity treatment. FDA Division Director John Sharretts said it clearly: “This patient population has […]