Hurry up and wait appears to be the word from the U.S. Food and Drug Administration (FDA) when it comes to the safety of medical devices. The agency was supposed to have issued a final proposal by the end of June on a mandate to make it easier to identify […]
Category: Articles
It is a startling revelation concealed in court documents – C.R. Bard, one of the six primary plastic mesh manufacturers – knowingly sold vaginal and hernia mesh that was made of a material unsuitable for human implantation. What’s worse was that court documents show executives knew the Marlex polypropylene should […]
They are advertised on the web and in retail stores as sex supplements, but the Food and Drug Administration (FDA) says the products contain hidden drugs. The names are catchy – Nights to Remember, Cave Diver, Super Cheetah and Reload, but an FDA laboratory says it has identified the drug […]
A new analysis of federal data finds that pain pill addiction is now a woman’s problem that has spiked 400 percent in recent years. It used to be that more men were addicted to pain pills, men who did backbreaking physical labor, but since 1999 there has been a turnaround. […]
Unlike other countries, the United States has no way to monitor medical devices after they are approved and used or implanted in patients. It is sort of the Wild West out there. When a medical device is defective and injures a patient, the patient, her doctor or lawyer have the […]
It may sound good – bee pollen, green tea, all natural ingredients, but the U.S. Food and Drug Administration (FDA) is warning consumers that Fat Zero is anything but natural. Consumers are being warned not to purchase Fat Zero for weight loss or any other reason. It is sold on […]
Statins are drugs that are commonly prescribed to lower cholesterol. It’s estimated about one-quarter of all Americans over the age of 45 with high cholesterol is prescribed a statin to avoid a heart attack or stroke. They are generally thought of as safe, but researchers have linked these drugs to […]
It is unclear what caused the deaths of two patients injected with the anti-psychotic medication Zyprexa, but the U.S. Food and Drug Administration is investigating. According to the FDA, the two died a few days after being injected with Zyprexa Relprevv. The drug’s warning label contains information about delirium sedation […]
Consumers may not realize it, but the U.S. Food and Drug Administration (FDA) currently has no way to track problems with medical devices and drugs that go wrong other than voluntary reporting. Unlike other countries that have drug and device registries, the FDA has an absolute head-in-the sand approach to […]
FDA agents have discovered that employees at the Houston office of Cetero Research tampered with records and manipulated test data. This firm has conducted research for drug companies worldwide. Chinna Pamidi, the testing facility’s president, bluntly admitted that much of the lab’s work was fraudulent, saying “You got us” when […]