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.
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.
April 9, 2013 |
The Food and Drug Administration on Monday approved a drug to treat the severe nausea and vomiting that some women experience during early pregnancy. The Canadian-made medication will be marketed as Diclegis. It is the only prescription medication approved for pregnant women experiencing "morning sickness" that does not go away with a bland diet of small meals that are low in fat. Diclegis was once known and marketed in the United States as Bendectin and taken by as many as one in 10 pregnant women.
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 20, 2013 |
Daesang America Inc. is recalling packages of sesame- and garlic-flavored mixed soy bean paste because they may contain undeclared peanuts, according to the U.S. Food and Drug Administration. People who are allergic to peanuts run the risk of a serious or life-threatening allergic reaction if they consume these products, according to the FDA. The packages were sold in stores nationwide, and online. No injury or illness has yet been reported. "The product comes in a 500 gram (17.64 ounce)
June 18, 2013 |
The Food and Drug Administration says it is investigating the unexplained deaths of two patients in the wake of receiving intramuscular injections of the antipsychotic medication Zyprexa (generic name olanzapine). The patients died three to four days after receiving appropriate doses of Zyprexa Relprevv, which is designed to release slowly into the blood over two to four weeks and provide regular dosing for adults with schizophrenia. The FDA says the deaths occurred well after the three-to-four-hour window following injection during which patients should be monitored in a physician's office for a potentially deadly complication called post-injection delirium sedation syndrome (PDSS)
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.
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 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.
June 21, 2011 |
The Food and Drug Administration says it could use an international helping hand in testing the influx of imported drugs and food. Acknowledging the monitoring difficulties inherent in a global economy, the agency said in an announcement Monday that it needs to transform the way it protects the nation's food and drug supply, teaming up with other agencies around the world to ensure quality and safety of the products it regulates. “Global production of FDA-regulated goods has exploded over the past ten years. In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities, making the distinction between domestic and imported products obsolete,” Commissioner of Food and Drugs Margaret A. Hamburg said in the announcement.