The 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. The single-use, N95 surgical respirator is designed for use in health care settings by health care personnel to protect against microorganisms, body fluids, and particulate material.
The agency rejected all 26 opposing comments it received, including a letter from Public Citizen that FDA addressed point by point.
When the European Food Safety Authority published its opinions April 8 on 442 proposed health claims for food products, it rejected 80 percent of them.
Consumers can now search for food and other product recalls easier and quicker on the Food and Drug Administration's website as search results now provide data from news releases and other recall announcements in the form of a table. That table organizes information from news releases on recalls since 2009 by date, product brand name, product description, reason for the recall and the recalling firm.
At least 26 U.S. workers were killed in grain entrapments last year, and the numbers of entrapments are increasing, according to researchers at Purdue University.
“Restricting sodium is particularly important in lowering blood pressure among more sedentary people," said Casey M. Rebholz, M.P.H., lead author of the study.
The Food and Drug Administration and the European Medicines Agency have launched a new pilot program that will allow parallel evaluation of relevant development and manufacturing data components, known as Quality by Design, of new drug marketing applications that are submitted to both agencies.
The Food and Drug Administration will hold the meeting March 29 to hear from stakeholders about the import safety provisions of the new law.
Low or no coffee consumption was associated with an increased risk of stroke in a study of 34,670 women (ages 49 to 83) followed for an average 10.4 years.
The Food and Drug Administration recently approved Benlysta (belimumab) to treat patients with active, autoantibody-positive lupus (systemic lupus erythematosus) who are receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs.
Several federal agencies, including the National Institutes of Health, recently unveiled a new high-speed robot screening system that will test 10,000 different chemicals for potential toxicity.
The Food and Drug Administration recently took action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products. The affected products cannot be legally marketed in the United States.
OSHA issued the willful citation to Associated Milk Producers for allegedly failing to fully implement and properly install fall protection for workers performing milk unloading operations. Additionally, two serious citations were issued for not providing training, evaluation, and certification for operators of powered industrial vehicles.
Following the diacetyl hazard scare, many food manufacturers turned to flavor alternatives -- only to find out their problems had followed them.
The regulations require specific allergens, sulfites above 10 ppm, and gluten sources be disclosed on a new label. They take effect Aug. 4, 2012, giving industry 18 months to implement the changes.
Government regulators could more realistically assess the value of improving food safety if they considered the fact that consumers typically want to avoid getting sick--even if it means they have to pay a little extra for safer food, researchers said.
Housekeeping and buying the right mat for the task and location are essential parts of the solution for food service companies.
Bridgford Foods' Chicago facility has been inspected by OSHA three times since November 2007, resulting in 29 health and safety citations.
Part of the agency’s ongoing transparency initiative, the site is one of the 19 action items contained in a 46-page report titled “FDA Transparency Initiative: Improving Transparency to Regulated Industry.”
Seven hundred German farms closed for inspection have been allowed to reopen, but the dioxin contamination has shaken authorities, who are discussing how to prevent this from recurring.