Last week's FDA approval of a novel cancer treatment is nothing short of historic. Not only does it give long-overdue hope to patients suffering from pediatric leukemia, but it also opens up a world of new treatment possibilities for other forms of this horrific disease.
The story of the allegedly toxic (and potentially lethal) homeopathic teething products continues. The latest piece of the puzzle is the multiple violations an FDA investigation uncovered at Raritan Pharmaceuticals, one of the company's manufacturing facilities.
Who hasn’t chuckled at a TV prescription drug ad, during its litany of wide-ranging potential side effects? Anal leakage and the oft-repeated erections lasting more than four hours? With direct-to-consumer marketing, product overstatements of health benefits with simultaneous minimization of possible harms have become the norm. Now, the FDA wants to change that.
Just because you did something once last year in Mexico does not mean you can do it here. That is the message the US Food and Drug Administration (FDA) is sending to a physician in New York. Dr. John Zhang runs the New Hope Fertility Center. The center, located in a high rent district of Manhattan, is in the business of infertility treatments which are generally not a problem. It is, specifically, fertility treatments using mitochondrial DNA (mtDNA) replacement therapy (MRT) that were banned. Dr. Zhang started marketing this type of treatment through the website of his company Darwin Life (the website was not available at the time of this writing.)
The FDA announced new regulations on tobacco products — some good, some not so great. We'd like to see the data supporting the idea that lowering the nicotine level in cigarettes would be less addictive. But we applaud the move to give tobacco manufacturers more guidance and time to apply for approval of their products.
The Food and Drug Administration is cracking down on the use of opioid-containing drugs for children. Is this an overreaction? Maybe.
April is autism awareness month and the FDA isn't missing a beat, warning about fraudulent autism treatments – like chelation therapies and detoxifying clay baths. Not only are they expensive, they're completely ineffective. It's time to smoke out these snake oil salesmen who are preying on parents who just want to help their kids.
The Standard Homeopathic Co. issued a voluntary recall of its teething products, sold under the name Hyland, after the FDA repeatedly cited concerns over inconsistent – and excessive – levels of Belladonna, a toxic chemical.
We're currently in the middle of the FDA's open-comment period on genetically edited foods. To date, 191 comments have been submitted, the majority expressing a sentiment of "poisoning the people." Well, scientists and pro-science folks, now's the time to make the scientific community's voice heard. Here's how to do it.
The controversy over GMOs lives on, despite the scientific community's best efforts to quell the scaremongering. In order to gather the public's concerns, the FDA is requesting comments on the topic of genome editing, in the production of plants that would be eaten by both humans and animals.
The FDA confirmed the presence of of the poisonous substance, belladonna, in the homeopathic teething remedies linked to the deaths of 10 infants. More importantly, its analysis detected amounts that were inconsistent between samples, meaning some of the levels were much higher than what the product's label indicated.