Medical
The Defibrillator That Fails May Be The One You Need
August 1, 2012 12:58 pm | by Karl Stephan, Consulting Engineer, Texas State University, San Marcos | Blogs | CommentsAEDs 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.
Judge Lets Challenge To FDA Tobacco Panel Proceed
August 1, 2012 12:25 pm | by Michael Felberbaum, AP Tobacco Writer | News | CommentsIn the suit, the tobacco companies allege that the panel fails to meet the federal requirements that committee members should be fairly balanced.
Fake It Until We Make A Change
July 31, 2012 1:53 pm | by Jonnatha Mayberry, Associate Editor, Chem.Info | Blogs | CommentsNothing’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.
Perrigo Sells Plant To Medline
July 23, 2012 11:00 am | News | CommentsThe 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.
The Little Things That Kill
July 22, 2012 2:58 am | by Jeff Reinke, Editorial Director | Blogs | CommentsLike 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.
Report: J&J Will Pay $2.2B In Risperdal Settlement
July 20, 2012 1:30 am | News | CommentsThe settlement will include a $400 million criminal fine for paying out illegal kickbacks so that more nursing homes would prescribe the anti-psychotic drug.
Anticipated Weight-Loss Pill Wins FDA Approval
July 18, 2012 1:57 am | by Matthew Perrone, AP Health Writer | News | CommentsThe pill, called Qsymia, underscores how difficult it has been for drugmakers to find obesity treatments that are safe and effective.
Australian Wins Millions In Thalidomide Lawsuit
July 18, 2012 1:47 am | by Kristen Gelineau, Associated Press | News | CommentsAn 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.
Recalls, Quality Push J&J Profit Down
July 17, 2012 9:40 am | News | CommentsJohnson & Johnson said Tuesday that its second-quarter net income fell by half due to lower sales and charges for litigation.
TPG Buying Par Pharma For $1.84 Billion
July 16, 2012 10:48 am | News | CommentsThe 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.
GE Invests In Myanmar After U.S. Eases Sanctions
July 16, 2012 10:23 am | by Yadana Htun, Associated Press | News | CommentsJust days after the U.S. eased key sanctions on Myanmar, General Electric became the first American company to invest in the former pariah state.
J&J In Tentative Deal On Lawsuit
July 13, 2012 10:09 am | News | CommentsJohnson & 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.
Study: Global Spending On Drugs Slowing Quickly
July 12, 2012 1:53 pm | by Linda A. Johnson, AP Business Writer | News | CommentsA 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 Gets Apology From China Agency
July 11, 2012 2:19 pm | News | CommentsMead Johnson and other makers of baby formula were accused of using vanillin, a common vanilla substitute, which is not allowed in products for infants.
Medtronic Gets New Label For Anti-Snoring Implant
July 11, 2012 2:15 pm | News | CommentsThe new label indicates that physicians can implant up to five of the anti-snoring devices even though the FDA has only approved three.
Texas Switches To 1-Drug Execution Due To Shortage
July 11, 2012 10:12 am | by Nomaan Merchant, Associated Press | News | CommentsPentobarbital, 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.
India's Ranbaxy Planning Expansion In U.S.
July 10, 2012 12:13 pm | by Linda A. Johnson, AP Business Writer | News | CommentsCEO Arun Sawhney said the company is aiming to regularly be first on the U.S. market with just-approved generic drugs.
Bones Made Of Titanium
July 10, 2012 11:15 am | by Tim Daro, Siemens | Articles | CommentsSubstantial 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.
Improve Your Business With Certified Products
July 9, 2012 12:46 pm | by Jay Tourigny, Senior Vice President, MicroCare | Articles | CommentsDesign 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.
Pimp My Prosthetic
July 9, 2012 11:54 am | by Meaghan Ziemba, Associate Editor, PD&D | Articles | CommentsBespoke Innovations uses 3D scanning to capture and accurately recreate to produce a custom form that changes the way the world views prosthetics.
Extending The Life Of Electronics
July 6, 2012 12:19 pm | by Jeff Spence | Blogs | CommentsNo 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.
GlaxoSmithKline To Pay $3 Billion For Health Fraud
July 2, 2012 1:17 pm | by Jesse J. Holland, Associated Press | News | CommentsProsecutors said the company illegally promoted two drugs for unapproved uses, and demanded it be monitored by the FDA for five years to ensure compliance.
Linde To Buy U.S. Firm Lincare For $4.6 Billion
July 2, 2012 9:53 am | News | CommentsThe 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.
Bristol-Myers To Buy Diabetes Drug Maker For $5B
July 2, 2012 9:46 am | News | CommentsDiabetes is a growing focus for drugmakers as more people are diagnosed with the disease, partly due to rising obesity levels.
Proposed Vt. Bio-Tech Plant Could Create 500 Jobs
July 2, 2012 9:37 am | News | CommentsAnC Bio, a South Korean company that manufactures artificial organs, will spend build a $50 million plant that could also lease out clean rooms to business from around the world.
