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.
Category Archives: Food Safety News
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
Magic Valley Fresh Frozen, Inc. Foods Issues Allergy Alert On Undeclared Milk In Breaded Okra
McAllen, TX Magic Valley Fresh Frozen, Inc. announced today that it is voluntarily recalling breaded okra produced under the HEB label from July 1, 2010 through January 31, 2011 because the product may contain undeclared whey (a milk ingredient).
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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.
FDA orders postmarket surveillance of certain TMJ implants
TMJ, postmarket, surveillance
FDA approves drug to reduce risk of preterm birth in at-risk pregnant women
The U.S. Food and Drug Administration today approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least one spontaneous preterm birth.