Posts Tagged 'DePuy'

The U.S. Food and Drug Administration has issued what the agency is describing as a “first-of-a-kind guidance” to help medical device manufacturers get through the review process for new devices.

The FDA is issuing the document, titled “Factors To Consider When Making Benefit-Risk Determinations in Medical Device Premarket Approval and De Novo Classifications,” to address problems that have come up recently as a result of the agency’s approval process.

An FDA spokeswoman has been quoted as saying: “The devices center identified several ...

According to a news release by the Consumers Union, a Senate committee is scheduled to discuss legislation that would fail to correct a loophole allowing dangerous medical devices to make it onto the market.

The Consumers Union is the policy and advocacy arm of Consumer Reports.

On April 25, the Senate Health, Education, Labor and Pensions Committee was scheduled to mark-up legislation to reauthorize the Food and Drug Administration Safety and ...

A post on stock market information Website Seeking Alpha says Johnson & Johnson will likely deal with significant public backlash going forward. An Arkansas jury recently concluded that the company used deceptive tactics to market antipsychotic drug Risperdal, which included hiding or minimizing the drug’s risks. A judge then issued a $1.2 billion fine.

The post says the fine leveled against Johnson and Johnson and subsidiary Janssen Pharmaceuticals is the largest ...

An internal document from the U.S. Food and Drug Administration defends the agency’s rejection of European standards for approving medical devices, according to a report in the Minneapolis-St. Paul Star Tribune.

The FDA document amounts to the agency’s defense of its own practices, and describes 12 classes of allegedly “unsafe and ineffective” high-risk medical devices approved for sale in Europe but not the United States.

According to the Star Tribune, the United ...