AEDs are medical devices, aren’t they? And so they must go through the same rigorous Food and Drug Administration qualification and inspection tests as other medical devices, mustn’t they? Well, not quite, it turns out. AEDs are in a kind of legal gray area that allows manufacturers simply to say that their product is “substantially equivalent” to other AEDs.
In the suit, the tobacco companies allege that the panel fails to meet the federal requirements that committee members should be fairly balanced.
Nothing’s worse than being put on prescription after prescription while your physician attempts to find a cure all of your symptoms, right? Wrong. In reality, there is something that is worse than ineffective medicine: drugs that not only don’t work, but also cause serious harm. The current counterfeit drug crisis is nothing short of an epidemic. And, although this epidemic doesn’t seem to be growing, it doesn’t seem to be slowing either.
The companies did not disclose terms. Medline will use the facility to make products including enema and douche products, as well as and oral saline laxatives.
Like all design engineers, Thom Haubert is a problem solver, but one of his latest projects offered the ultimate challenge in solving a puzzle with literally billions of pieces.
The settlement will include a $400 million criminal fine for paying out illegal kickbacks so that more nursing homes would prescribe the anti-psychotic drug.
The pill, called Qsymia, underscores how difficult it has been for drugmakers to find obesity treatments that are safe and effective.
An Australian woman will receive a multi-million settlement from British distributor of the anti-morning sickness drug that she says caused her to be born without arms and legs.
Johnson & Johnson said Tuesday that its second-quarter net income fell by half due to lower sales and charges for litigation.
The generic drug maker Par Pharmaceutical Cos. has agreed to be acquired for about $1.84 billion in cash by an affiliate of private investment firm TPG.
Just days after the U.S. eased key sanctions on Myanmar, General Electric became the first American company to invest in the former pariah state.
Johnson & Johnson stockholders, trying to restore high standards, have reached a tentative settlement in their lawsuit against J&J's board and top executives for allegedly letting serious legal and manufacturing problems continue for years.
A slew of new low-cost generic drugs will reduce loads on patients and insurers, while drug companies will grow quickly in developing countries.
Mead Johnson and other makers of baby formula were accused of using vanillin, a common vanilla substitute, which is not allowed in products for infants.
The new label indicates that physicians can implant up to five of the anti-snoring devices even though the FDA has only approved three.
Pentobarbital, one of three drugs Texas used previously, is now in short supply after its Danish manufacturer said it would try to prevent its use in executions.
CEO Arun Sawhney said the company is aiming to regularly be first on the U.S. market with just-approved generic drugs.
Substantial legal requirements result in more complex functional specifications for the implant manufacturers: From the design - including the materials — through production, the complete process chain must be documented and validated. CNC-controlled high-tech machines support the prosthetics manufacturers, and permit high-quality products to be manufactured despite the continuing pressures of high cost.
Design and manufacturing engineers strive to develop high-quality devices in a budget-conscious manner, but some challenges can potentially prevent the device from going to market.
Bespoke Innovations uses 3D scanning to capture and accurately recreate to produce a custom form that changes the way the world views prosthetics.
No two disturbances are the same, and the increased complexity of these disturbances has proven to be catastrophic to the lifespan and reliability of medical equipment.
Prosecutors said the company illegally promoted two drugs for unapproved uses, and demanded it be monitored by the FDA for five years to ensure compliance.
The German-based company that specializes in industrial and medical gases said it is looking to get a bigger slice of the growing health care market.
Diabetes is a growing focus for drugmakers as more people are diagnosed with the disease, partly due to rising obesity levels.