The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Dr. Joshua Sharfstein, deputy commissioner of the Food & Drug Administration, is stepping down for the top job in Maryland’s public health department, according, un-named officials told the Wall Street Journal.
Medtronic Inc. (NYSE:MDT) won Food & Drug Administration approval for its Endurant stent for abdominal aortic aneurysms.
The Fridley, Minn.-based medical device giant’s device, which is delivered via catheter through the femoral artery, won CE Mark approval in the European Union in 2008 and is in use in roughly 100 countries, according to Medtronic.
Airgas Inc. (NYSE:ARG) and Steris Corp. (NYSE:STE) were both slapped with Food & Drug Administration warning letters.
Radnor, Pa.-based Airgas Inc.’s violations included the company’s failure to adequately expand an investigation of a contaminated nitrogen cylinder and filling batches of medical gas products without completing production records, according to the the watchdog agency’s letter.
Could the next “blockbuster” drug be a combination of existing therapies? The Food & Drug Administration seems to think so.
The federal watchdog agency issued draft guidelines yesterday intended to encourage pharmaceutical companies to develop therapies from drug combinations.
The agency feels that despite the increased risk involved in combining pharmaceutical treatments, there are benefits to treating serious diseases such as cancer.
Last year the Food & Drug Administration ruled that the mercury-containing metal in dental fillings is safe, but the agency wants to know if the methods it used to determine the alloy’s safety were satisfactory.
The FDA is holding a public meeting today and tomorrow on the issue, focusing on the risk of the dental amalgam for children and pregnant women.
510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD November 2010DEVICE: RANDOX ETHANOL ASSAY
RANDOX LABORATORIES, LTD. 510(k) NO: K092273(TRADITIONAL)
ATTN: P. ARMSTRONG PHONE NO : 44 28 94422413
55 DIAMOND RD. SE DECISION MADE: 01-NOV-10
CRUMLIN, COUNTY ANTRIM UK BT29 510(k) SUMMARY AVAILABLE FROM FDADEVICE: ELECSYS CA 125 II CALCHECK 5
ROCHE DIAGNOSTICS 510(k) NO:
Minnesota, Sens. Amy Klobuchar (D) and Al Franken (D) along with Rep. Erik Paulsen (R), have championed the medical device industry with speeches and letters to the Food & Drug Administration about upcoming changes to the 510(k) approval program.
The FDA is now close to releasing its recommendations on 510(k) changes and Minnesota’s congressional delegation is again beginning to show its support for the medical device industry.
The Food & Drug Administration today finalized the draft for procedures that the public must following to participate in the agency’s open meetings.
The watchdog agency holds open advisory committee meetings in an attempt to involve the public and representatives from the drug and medical device industry in its decision-making.
FDA Webview (paid) reports that the new Food & Drug Administration associate commissioner for external affairs, Beth Martino, 31, a former Kansas aide to HHS secretary Kathleen Sebelius, has conducted a purge of senior specialists, all aged over 50, in her office and in the press office.
Center for Devices and Radiological Health director Dr. Jeffrey Shuren strongly refuted findings from a recently study that said more than three-quarters of the cost to bring a medical device from concept to the U.S. market is spent clearing regulatory hurdles.
Shuren told MassDevice that a study by researchers at Stanford University titled “FDA Impact on U.S. Medical Technology Innovation,” which said that millions of U.S. patients were being denied or delayed access to leading medical devices that are first (or exclusively) brought to market in other countries, was “highly flawed.”
Industry and the American public have lost faith in the federal agency in charge of overseeing the country’s drug and medical device industry, according to an annual survey by PricewaterhouseCoopers LLP.
PWC and Biocom, a trade association representing 550 California life science firms, interviewed 1,000 individuals and executives at 50 medical device, drug and diagnostic companies. The pollsters found that slightly more than half (51 percent) expressed a favorable opinion of the Food & Drug Administration’s performance, but that high-profile drug recalls had damaged confidence in the watchdog agency.
