November 22, 2010 |
Medical innovation saves lives, but each drug and device requires careful scrutiny by the Federal Drug Administration before being deemed safe to market. But does the federal agency take too long in its approval process? Dr. Josh Makower says yes. The consulting professor of medicine at Stanford University co-wrote a study of 200 medical technology companies and reports his findings in this column by Nicole Brochu of the South Florida Sun Sentinel . The column reads in part: "For low- and moderate-risk devices, the process to navigate the FDA took companies on average three months to two years longer for a green light than it did for a similar approval from European regulators.
November 16, 2012 |
The Food and Drug Administrationon Friday posted additional adverse event reports connecting two more energy drinks to 53 illnesses, five deaths and two chronic disabilities. The new information comes on the heels of an FDA announcement linking the extremely popular 5-Hour Energy shots to 92 sicknesses and 13 deaths. The latest reports do not prove that the drinks -- Monster Energy and Rockstar Energy -- caused the illnesses or deaths, but rather register the fact that a doctor, family member, or patient believes the product might have played a role.
August 2, 2011 |
A coalition of nearly 30 organizations in the animal agriculture industry sent a letter to the heads of the House and Senate on Tuesday, asking lawmakers not to intervene as the Food and Drug Administration considers whether to approve genetically engineered salmon as food. The letter comes more than a month after the House approved an amendment, by voice acclamation, to an appropriations bill that would strip the FDA of funding to study the salmon. On July 15, members of the House and Senate sent letters to the FDA asking it to abandon its consideration of modified salmon as food, and threatened to propose legislation to bar further study of the fish if the agency does not comply.
February 2, 2012 |
Trace levels of the fungicide carbendazim were discovered in domestic orange juice samples, the Food and Drug Administration reported Thursday. But the FDA said the levels pose no safety risk, and the orange juice will not be recalled. FDA spokeswoman Siobhan DeLancey said that most of the samples taken were from concentrated products that will be blended down into the orange juice consumers drink, so the low levels of carbendazim will almost disappear. “We didn't have any evidence to indicate that the product on the market was any safety problem at all,” DeLancey said.
September 14, 2010
The Food and Drug Administration released information Tuesday suggesting it's unimpressed by a weight-loss medication under development by Arena Pharmaceuticals Inc. and casting doubt on the drug's eventual approval. An FDA advisory committee is scheduled to meet Thursday and vote on whether to recommend approval of the drug, lorcaserin. But in documents released Tuesday in advance of the meeting, the FDA noted that studies on lorcaserin showed the average weight loss while taking the drug was not significantly different than the average weight loss among people taking a placebo.
March 21, 2013 |
La Preferida Inc. is voluntarily recalling 56,808 29-ounce cans of La Preferida Whole Pinto Beans, the U.S. Food and Drug Administration announced Thursday. "The manufacturer's preliminary inspection indicates 420 cans may not have been fully processed, which could result in product contamination by spoilage organisms or by pathogens, which could lead to illness if consumed," the FDA said. "To date, there have been no reported injuries or adverse events associated with the consumption of this product.
January 7, 2011 |
By late March, tobacco companies will have to reveal to the Food and Drug Administration what sorts of new additives they've recently put in their products. But the ruling doesn't apply to electronic cigarettes, whose makers are locked in legal battle with the FDA. Meanwhile, the e-cigs are starting to gain a pop-culture foothold – in the fall film “The Tourist,” actor Johnny Depp extols the devices’ virtues to Angelina Jolie, and Katherine Heigl showed up recently on the "Late Show with David Letterman" smoking the e-cigarette indoors.
December 27, 2010 |
Remoxy may not have the name recognition of Percocet, but its makers say it has something Percocet and similar drugs don't have -- little potential for addiction. They've asked, again, that the FDA approve Remoxy. Like Percocet, Remoxy contains oxycodone, an opiate that Americans like quite a bit. Unlike other formulations, however, Remoxy employs a special controlled-release formula designed to limit its abuse. The National Institute on Drug Abuse reports that of 7 million Americans abusing prescription drugs in 2009, 5.3 million were abusing pain relievers.
February 12, 2014 |
The U.S. Food and Drug Administration is investigating the illnesses of children in three states in recent months that have been linked to Uncle Ben's infused rice served in schools. The cluster of illnesses have affected children in Texas, Illinois and North Dakota. At three schools in Katy, Texas, 34 students and four teachers experienced skin reactions, burning, headaches and nausea last week after eating Uncle Ben's "Mexican flavor" infused rice. The symptoms lasted about 90 minutes, officials said. Similar reactions were reported at an Illinois school in December and a daycare center in North Dakota in October. Mars Foodservices, which produces the product, has recalled 5- and 25-pound bags of various rice products primarily sold to schools, restaurants, hospitals and other commercial establishments.
December 3, 2010 |
Invisible braces sound perfect, especially if you're an adult trying to look and act your age. But the FDA says Invisalign, which makes one type of invisible braces, failed to report information on side-effects in patients. Here's the Associated Press story detailing some patients' complaints about allergic reactions to the devices and the FDA advisory letter . And, of course, the response from Invisalign maker Align Technology Inc. in San Jose. None of this is to say that crooked teeth should stay crooked.