One of the difficulties that federal regulators ran into during the nationwide scandal surrounding the New England Compounding Center — the Massachusetts-based pharmacy blamed for a nationwide fungal meningitis epidemic that has sickened hundreds and killed dozens — was the issue of when such pharmacies cross the line from compounding to manufacturing.
Food and Drug Administration commissioner Margaret Hamburg faced strong criticism Tuesday in a hearing before the House Committee on Energy and Commerce to investigate the nationwide outbreak of fungal meningitis linked to a Massachusetts compounding pharmacy, but she conceded the agency could have done more.
An inspection of more than two-dozen compounding pharmacies by Food and Drug Administration officials has found widespread problems with sanitation and sterilization practices, FDA commissioner Margaret Hamburg wrote in a blog post on the agency's website Thursday.
The Food and Drug Administration has 30 days to approve over-the-counter availability of the emergency contraceptive Plan B One-Step to women of all ages, according to a decision issued by Judge Edward Korman of the U.S. District Court, Eastern District of New York.
A group of doctors and public health professors are hoping the Food and Drug Administration will place stronger regulations on energy drinks to protect children and adolescents from what they call the harmful effects of high caffeine consumption.
New York is hoping to battle the theft of highly addictive prescription drugs, such as Oxycontin, by stocking pharmacies with fake pill bottles that are fitted with GPS tracking devices, according to published reports.
The New York Department of Health on Monday announced that reported cases of influenza are increasing throughout New York, and flu activity in the state is now considered to be widespread, with laboratory-confirmed cases in more than half the regions.
Food and Drug Administration commissioner Margaret Hamburg is asking Congress to give the agency more power to regulate compounding pharmacies amid a national meningitis outbreak linked to a Massachusetts-based compounding pharmacy that has claimed dozens of lives nationwide.
New York City Mayor Michael Bloomberg and Health Commissioner Thomas Farley received their seasonal flu vaccination Thursday morning at a Duane Reade pharmacy in New York City, demonstrating the importance of taking proactive steps to prevent the spread of influenza.
The New York City health commissioner’s ban on the sale of big cups of fountain soda drew many an unfavorable accusation that the administration of mayor Michael Bloomberg was trying to turn the city into a nanny state, with NaturalNews.com editor Mike Adams asking, “What’s next? Is Bloomberg gonna pull a Singapore and ban chewing gum too?”
In partnership with international regulatory and law enforcement agencies, the Food and Drug Administration on Thursday announced it had taken action against more than 4,100 Internet pharmacies that illegally sell unapproved drugs to consumers.
Keynote speeches by pharmaceutical industry and regulatory leaders got top billing as more than 140 government, healthcare industry, law enforcement and patient advocacy officials gathered to find ways to combat the spread of counterfeit medicines.
A consumer group is urging the Food and Drug Administration to review a proprietary point-of-purchase nutrition rating system that it said is "inconsistent with FDA guidance statements and enforcement correspondence, federal nutrition programs and recommendations from the Institute of Medicine."
The number of new drug shortages has been halved as early notifications from manufacturers of potential shortages have increased sixfold, the commissioner of the Food and Drug Administration wrote Thursday.
“Straight over the cliff.” That may be the destination for many independent pharmacies now that the Federal Trade Commission has unconditionally approved the controversial merger of the nation’s second- and third-largest pharmacy benefit managers, a top pharmacy leader warned.