What Does FDA Approval Mean For You?

by Rebbeca Binder on November 7, 2013

(U. S. Personal Injury Claims law and generally) The Food and Drug Administration (FDA) is a government agency that was designed to protect consumers from dangerous foods, medications and medical devices. The FDA has established many different testing and product standards that businesses must comply with to sell their products in the United States.

The most common thing that the FDA is known for is the approval of new medications and medical treatments. The FDA requires extensive testing periods and clinical trials before it will allow a new medication or device to become available on the market. It is thought that this extensive testing period would protect the consumers. But this is not always the case.

Recalls and Relabeling

Sometimes, despite the extensive testing that was thought to have taken place before a medical product is available on the market, it is released and causes harm to many people. When this occurs, the FDA usually first requires the pharmaceutical company to re-label their product and post new warnings, unless the injuries are so severe that it requires immediate recall. If a product has been forced to be re-labeled, he FDA will begin an investigation to determine if there are other issues wrong with the product and if it needs to be removed from the market.

One of the more recent recalls has been the Stryker Hip Replacement Device. This device, intended to replace damaged hip joints, has been found to release metal shavings into the bloodstream, collapse under pressure, and even cause damage to surrounding tissue and muscle. If you have had a hip replacement and want to learn more, search for information about the Stryker hip recall online.

A labeling change was recently required by the makers of Januvia. This medication is used for the treatment of Type II diabetes. It was discovered that Januvia increases the risk of pancreatitis in patients that use the medication. The manufacturers were required by the FDA to place a black label warning on their medication stating this risk.

Other labeling issues usually occur in the food division of the FDA. The FDA will review products that are for sale and determine if the list of ingredients are complete. In many cases, if soy, nuts, whey, or milk are in the product but not on the label, the FDA will issue a recall of all available products and require the manufacturer to disclose their findings on the label.

What Does This All Mean To You?

The FDA is in place to make sure that consumers are protected from dangerous products. In most cases, they do their job very well. The FDA is very swift bout removing dangerous products from the market and demanding very high standards on product labeling and instructions.

However, sometimes they may not realize that a product is not exactly what it says or what the testing reveals. Several pharmaceutical companies and device manufacturers have been sued by the FDA itself for falsifying tests and providing fraudulent clinical studies.

If you are injured by one of these dangerous medications or failed medical devices, you should see compensation for your injuries. For more information about the Stryker hip recall speak to your medical provider. Speak to a personal injury attorney about your case. By standing up to these manufacturers, you may help protect others from the same type of injury.

Rebbeca Binder

Rebbeca Binder

Rebecca Binder is a stay-at-home mom to two daughters. She has been a freelance writer for five years and enjoys writing on topics relating to law and consumer information. Aside from her writing and family, her hobbies include playing piano and fitness.
Rebbeca Binder

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