The U.S. Food and Drug Administration cleared the SpectraShield 9500 N95 surgical respirator, a device that kills 99.99 percent of three different kinds of bacteria when exposed to its outer surface.
Category Archives: Drug Safety Information Podcasts
FDA permits marketing of first test to help diagnose dengue fever
The U.S. Food and Drug Administration today allowed marketing of the first test to help diagnose people with signs and symptoms of dengue fever or dengue hemorrhagic fever, a leading cause of illness and death in the tropics and subtropics.
FDA clears test for bacteria that can cause serious intestinal disease
The U.S. Food and Drug Administration today cleared a test called the Cepheid Xpert C. difficile/Epi assay that is designed to rapidly detect the toxin B gene associated with Clostridium difficile infection (CDI), a cause of diarrhea that can lead to colitis, other serious intestinal conditions and death in severe cases.
FDA approves Horizant to treat restless legs syndrome
On April 6, the U.S. Food and Drug Administration approved Horizant Extended Release Tablets (gabapentin enacarbil), a once-daily treatment for moderate-to-severe restless legs syndrome (RLS).
FDA approves new treatment for rare form of thyroid cancer
medullary, thyroid cancer
FDA approves new device to treat brain aneurysms
The U.S. Food and Drug Administration today approved a new device that provides neurointerventional surgeons with another tool to treat brain aneurysms without performing open surgery.
FDA acts to prevent contamination problems with Triad antiseptic products
U.S. Marshals seize drug products manufactured and distributed by Wisconsin firms
FDA launches consumer-friendly Web search for consumers during recalls
Beginning today, consumers can search for food and other product recalls easier and quicker on FDA’s website than previously. The FDA Food Safety Modernization Act (FSMA) signed into law in January by President Obama called for a more consumer-friendly recall search engine. DSK
FDA proposes draft menu and vending machine labeling requirements, invites public to comment on proposals
The U.S. Food and Drug Administration today issued two proposed regulations regarding calorie labeling on menus and menu boards in chain restaurants, retail food establishments, and vending machines. The FDA invites input on the proposed regulations by visiting http://www.regulations.gov. (SY)
FDA Issues Statement on Makena
On February 3, 2011, the Food and Drug Administration approved the drug Makena (hydroxyprogesterone caproate) for the reduction of the risk of certain preterm births in women who have had at least one prior preterm birth. KV Pharmaceuticals, the drug’s owner, received considerable assistance from the federal government in connection with the development of Makena by relying on research funded by the National Institutes of Health to demonstrate the drug’s effectiveness. It also obtained seven years of exclusivity under the Orphan Drug Act, obtained approval under FDA’s accelerated approval program, and received expedited review.