The Ridascreen Norovirus 3rd Generation EIA assay is for use when a number of people have simultaneously contracted gastroenteritis and there is a clear avenue for virus transmission, such as a shared location or food.
Category Archives: Drug Safety Information Podcasts
FDA approves product to prevent bleeding in people with rare genetic defect
The U.S. Food and Drug Administration today approved Corifact, the first product intended to prevent bleeding in people with the rare genetic defect congenital Factor XIII deficiency.
FDA warns against certain uses of asthma drug terbutaline for preterm labor
The U.S. Food and Drug Administration is warning that terbutaline administered by injection or through an infusion pump should not be used in pregnant women for prevention or prolonged (beyond 48-72 hours) treatment of preterm labor due to the potential for serious maternal heart problems and death. In addition, oral terbutaline tablets should not be used for prevention or treatment of preterm labor. The FDA is requiring the addition of a Boxed Warning and Contraindication to the drug prescribing information (labeling) to warn against these uses.
U.S. Marshals seize Auralgan Otic Solution
U.S. Marshals, at the request of the U.S. Food and Drug Administration, yesterday seized all lots of Auralgan Otic Solution, a prescription drug used to treat pain and inflammation associated with ear infections.
FDA finalizes regulation for certain software, hardware used with medical devices
Today, the FDA issued a final rule that provides a less-burdensome path to market for certain hardware and software products used with medical devices. The rule classifies these products, known as Medical Device Data Systems or MDDS, as Class I or low-risk devices, making them exempt from premarket review but still subject to quality standards.
FDA seeks to invest in foodborne illness prevention, medical product safety and countermeasures
The U.S. Food and Drug Administration is requesting a budget of $4.3 billion to protect and promote the public health as part of the President’s fiscal year (FY) 2012 budget — a 33 percent increase over the FDA enacted budget for FY 2010. The FY 2012 request covers the period of Oct. 1, 2011, through Sept. 30, 2012.
FDA clears test to help patients with kidney transplants
Zortress, kidney, transplant
FDA approves first 3-D mammography imaging system
Mammography, screening, 3-D
FDA approves 1st pacemaker designed to work safely during some MRI exams
The U.S. Food and Drug Administration today approved the first heart pacemaker designed to be used safely during certain magnetic resonance imaging (MRI) exams.
FDA launches Medical Device Innovation Initiative
Today the U.S. Food and Drug Administration proposed the Innovation Pathway, a priority review program for new, breakthrough medical devices and announced the first submission: a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program. The FDA also announced plans to seek further public comment before the Pathway can be used more broadly.