The Food and Drug Administration recently announced it has stepped up its efforts to prevent non-compliant investigators and others from participating in new product development. FDA's procedures for debarment and disqualification have been enhanced to better protect participants in clinical studies and for ensuring the safety and effectiveness of the medical products marketed to the American public.
In a guidance issued Aug. 6, the Food and Drug Administration says that certain pharmaceutical ingredients used in the manufacture or preparation of drug products should be tested for melamine.
The Food and Drug Administration is requiring stronger warnings in the prescribing information for a class of drugs known as TNF blockers. The warnings, which include an updated boxed warning, highlight the increased risk of cancer in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, the inflammatory bowel disorder Crohn's disease, and other inflammatory diseases.
Managed by the University of Florida, the alliance is known worldwide for approving training courses, trainers, and certifications for seafood safety programs.
The Food and Drug Administration and the European Medicines Agency (EMEA) have announced an agreement to launch a bilateral Good Clinical Practices (GCP) Initiative designed to ensure that clinical trials submitted in drug marketing applications in the United States and Europe are conducted uniformly, appropriately, and ethically.
Safety authorities around the world, working together in some cases, have focused recently on health issues, construction falls, hospital-associated infections, and aviation safety.
The Food and Drug Administration recently announced that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.
Foods may look, smell, and even taste fine can still harbor bacteria that can cause food poisoning. The July issue of <i>Mayo Clinic Women’s HealthSource</i> provides an overview of food storage safety and how to avoid bad bacteria, such as E. coli and salmonella.
The Food and Drug Administration recently announced that it is conducting a safety review of Xolair (omalizumab), a drug used to treat certain adults and adolescents with moderate-to-severe persistent asthma.
These guidelines will assist local, state, and federal agencies in preventing and managing foodborne disease outbreaks through planning, detection, investigation, control, and prevention.
The Food and Drug Administration has issued a draft guidance on the use of inks, pigments, flavors, and other physical-chemical identifiers (PCIDs) by manufacturers to make drug products more difficult to duplicate by counterfeiters, and to make it easier to identify the genuine version of the drug.
The Paterson, N.J.-based companies promised to make corrections, but they failed to do so, DOJ said. The government’s complaint requests a court order to stop the companies and its officer from manufacturing and distributing the products until needed corrections are made.
In a suit filed this week in New York, the government says the company has an extensive history of operating under unsanitary conditions and producing cheese contaminated with Listeria monocytogenes, a foodborne pathogen that can cause serious illness and death.
The Food and Drug Administration on July 7 announced a regulation expected to prevent each year 79,000 cases of foodborne illness and 30 deaths caused by consumption of eggs contaminated with the bacterium Salmonella enteritidis.
On Tuesday, FDA Commissioner Dr. Margaret A. Hamburg announced Michael R. Taylor, a former administrator of the Food Safety and Inspection Service and acting under secretary for Food Safety, is returning to FDA as her senior advisor.
As of last Thursday, according to CDC, 69 people from 29 states had been infected with the outbreak strain; 34 people had been hospitalized, nine with a severe complication called hemolytic uremic syndrome, but no one had died.
The Plainview, Minn.-based site is voluntarily recalling instant nonfat dried milk, whey protein, fruit stabilizers, and gums (thickening agents) that it has manufactured over the past two years and sold to industry customers, including distributors and manufacturers but not directly to the public.
U.S. Marshals, at the request of the Food and Drug Administration, have seized drug products manufactured by Caraco Pharmaceutical Laboratories Ltd. (Caraco), at the company's Michigan facilities in Detroit, Farmington Hills, and Wixom. The seizure also includes ingredients held at these same facilities.
The facility, which manufactures bottled water products, has had an injury and illness rate nearly 70 percent below the industry average for three years, OSHA said.
The beef products were produced April 21 and 22, 2009, and were shipped to distributors and retail establishments in Arizona, California, Colorado, Florida, Illinois, Michigan, Minnesota, Nebraska, Oregon, South Carolina, Tennessee, Utah, and Wisconsin.