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FDA 501(k) – aka, Substantially Equivalent

FDA Pre-market approval

Products such as new drugs and complex medical devices must be proven safe and effective before companies can put them on the market.

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Monsanto Roundup Lawsuits Centralized in MDL

Tractor spraying herbicide

In October 2016, a panel of federal judges created MDL No. 2741 to centralize dozens of Roundup lawsuits in one federal court, the U.S. District Court for the Northern District of California under Judge Vince Chhabria.

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FDA Class I Recall: Zimmer Biomet Comprehensive Reverse Shoulder Implant

Zimmer Biomet Comprehensive Shoulder Replacement

February 15, 2017, the FDA announced a Class I recall of the Zimmer Biomet Comprehensive Reverse Shoulder implant because these devices are fracturing at a higher rate than stated in the labeling. If this occurs, patients may need a revision surgery to remove or replace the device.

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What are Soft Tissue Injuries?

Soft tissue injury

Soft tissue injuries are one of the more common types of injuries suffered in motor vehicle accidents. They can also be one of the hardest types of injuries to prove, too.

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Gaining Market Approval for Medical Devices

FDA Market Approval

It is the responsibility of manufacturers to ensure the products they bring to market are safe for public use. While the US FDA reviews the products before going to market, what do medical device manufacturers do to gain market approval?

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Have You Been in An Accident? What Types of Damages Can You Recover?

Car Accident damages

Often the question arises as to how much money a claim is worth or how much an accident victim might be entitled to. Without knowing the details of your situation, that question can’t be answered; however, we can tell you that a fair settlement will depend on several factors such as the severity of your injuries, the medical treatments needed, and who was at fault or negligent to start.

Our knowledgeable staff is available at (877) 284-6600 to help answer your questions.

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Do IVC Filters Make a Difference?

IVC Filter lawsuits

A new study, published in the scientific journal, JAMA Surgical on September 28, 2016, suggests that IVC filters may not help people who are at risk of dangerous blood clots to improve their chances of survival.

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FDA Basics You Should Know

FDA in magnifying glass

The Food and Drug Administration (FDA) is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices, and by ensuring the safety of our nation’s food supply, cosmetics, and products that emit radiation.

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Personal Injury Lawsuits: The Basics

Personal Injury Lawsuits

Personal injury law enables a person to go to civil court and receive compensation (or be “made whole”) after suffering injuries due to someone else’s carelessness.

When you have questions, our knowledgeable staff is available at (877) 284-6600.

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FDA 101: Product Recalls

FDA 101 Product Recalls

Unfortunately, in recent years, drug and product recalls have become more common. Why? What happens and how does the process work? Who is responsible for making sure these products are adequately tested before hitting the market?

Questions? Our knowledgeable staff is available at (877) 284-6600.

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