CINCINNATI — Regulatory advances made during the Innovation Pathway 2.0 project to develop new treatments for end-stage renal disease may quickly be rolled throughout CDRH, center Director Jeffrey Shuren said Wednesday at the FDA/Xavier University MedCon Conference here.
The FDA may need to better match its regulations with those of key trading partners, a move that could benefit the increasingly global device industry, thanks to a new executive order (EO), 13609, signed by President Barack Obama Tuesday.
[UPDATED 05/04/2012] The Centers for Disease Control and Prevention (CDC) has advised healthcare personnel to avoid use of compounded products labeled as sterile from Franck’s during the ongoing investigation.
Sound Interventions Completes 'First-In-Human' Feasibility Trial of Ultrasound-Based Renal Denervation System For Resistant HypertensionMay 4, 2012 6:04 am | News | Comments
Sound Interventions, Inc. today announced the successful completion of the company's First-In-Human clinical trial to treat resistant hypertension. The study was performed by Dr. Petr Neuzil and a team of cardiologists at Holmolka Hospital in Prague, Czech Republic.
One of the biggest complaints about the U.S. regulatory system is that the clinical trials required to prove safety and efficacy are prohibitively expensive. But could technology help to justify that cost or reduce costly errors related to clinical trial design?
As part of the Mammography Quality Standards Act (MQSA), Congress mandated there be annual reporting of adverse actions taken against mammography facilities. Congress stipulated that the report be made available to physicians and the general public and...
The Presillion plus CoCr Coronary Stent on RX System is a metal stent that is mounted on a folded balloon attached to a catheter delivery system for placement into a blood vessel supplying blood to the heart (coronary artery). The stent is made of a...
Labeling, Approval Order, and Summary of Safety and Effectiveness for Presillion plus CoCr Coronary Stent on RX System (P110004).
Undeclared active ingredients may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels.
Roche Diagnostics Operations Elecsys Troponin I and Elecsys Troponin I STAT Immunoassays: Recall â€“ Doctors may receive a falsely low resultApril 24, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments
Customers should immediately discontinue use of any affected product.
Class I Medical Device Recall: Roche Diagnostics Operations, Inc., Elecsys Troponin I and Elecsys Troponin I STAT ImmunoassaysApril 24, 2012 8:31 am | by U.S. Food & Drug Administration | News | Comments
With certain types of plasma samples, doctors may receive a falsely low result (up to a maximum of 50% lower than the actual concentration of Troponin I). These incorrect results may cause serious adverse health consequences, including death.
The potential for hacking into software-operated medical devices could pose a serious patient safety risk, a board convened by the National Institute of Standards and Technology (NIST) maintains.
Stakeholders agree on the majority of the Medical Device User Fee Act (MDUFA) reauthorization legislation now before Congress, but that didn’t make a House health subcommittee hearing on device and drug user fees smooth sailing.
Risk of renal impairment, hypotension, and hyperkalemia with concomitant use of aliskiren with angiotensin receptor blockers (ARBs) or angiotensin converting enzyme inhibitors (ACEIs) in patients with diabetes.
Other?Sonic Generic Ultrasound Transmission Gel: Safety Communication - Risk of Bacterial ContaminationApril 18, 2012 10:30 am | by U.S. Food & Drug Administration | News | Comments
Exposure to contaminated product may lead to serious infections.
WASHINGTON, D.C. - Congressman Edward J. Markey (D-Mass.), a senior member of the Energy and Commerce Committee, which has jurisdiction over the Food and Drug Administration (FDA), issued the following statement after the Subcommittee on Health hearing on the discussion...
Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc: Recall - May Contain More Than Intended Fill VolumeApril 18, 2012 5:30 am | by U.S. Food & Drug Administration | News | Comments
Consequences of opioid pain medication overdose can be life-threatening, including respiratory depression (slowed breathing or suspension of breathing), and low blood pressure.
These reagents are used with the Abbott ARCHITECT Instrument System to identify certain virus proteins associated with hepatitis B virus (HBV). If these virus proteins are present, then the patient is likely to be infected with HBV.
Labeling, Approval Order, and Summary of Safety and Effectiveness for ARCHITECT HBsAg (P110029).
Harry and David Issues Allergy Alert on Undeclared Peanuts in Harry & David Premium Kansas City Style Barbeque AlmondsApril 13, 2012 8:31 pm | by U.S. Food & Drug Administration | News | Comments
Harry and David, is voluntarily recalling approximately 205 2 oz. bags labeled Harry & David Premium Kansas City Style Barbeque almonds, because the bags may contain peanuts. Peanuts are not declared as ingredients, but the label includes the statement "May contain trace amounts of...
• Moon Marine USA Corporation (also known as MMI) of Cupertino, Calif. is voluntarily recalling 58,828 lbs of a frozen raw yellowfin tuna product, labeled as Nakaochi Scrape AA or AAA. Nakaochi Scrape is tuna backmeat, which is specifically scraped off from the bones, and looks like a...
An FDA advisory panel unanimously recommended approval of a new tool for detecting breast cancer, but advised against Class I status for a preamendment device used for the same purpose.
The FDA and other agencies must provide expertise, training and tools to developing nations to improve their medical technology monitoring practices and prevent dangerous medical products from entering the U.S., according to an Institute of Medicine (IOM) report. The recommendation is one...
These are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions for February 2012.
Birth Control Pills Containing Drospirenone: Label Change-Products may be associated with a higher risk for blood clotsApril 10, 2012 10:31 am | by U.S. Food & Drug Administration | News | Comments
Women should talk to their healthcare professional about their risk for blood clots before deciding which birth control method to use.