Nursefriendly.com: FDA Food and Drug Administration

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Thursday, April 21, 2011

Hand sanitizers: don't kill MRSA or E. coli, says FDA - Health Key

Hey, hand sanitizers. You can only do so much – and preventing MRSA infection isn’t one of those things -- so stop over-promising! That was the gist of warning letters from the Food and Drug Administration to four makers of the popular products.
Apparently, the manufacturers of Staphaseptic, Safe4Hours, Dr. Tichenor’s and CleanWell products had suggested that various gels, protectants and what-not could protect against infection with methicillin-resistant Staphylococcus aureus bacteria. The FDA takes issue with that.
It wasn’t too enamored with claims about preventing infection from E. coli or the flu either.
The letter to one of the companies, which claimed their product kills 99.9% of MRSA, gives the general tone: “Below is an analysis of the regulatory status of Staphaseptic First Aid Antiseptic/Pain Relieving Gel which includes excerpts of the violative labeling and the specific new drug and misbranding charges. Note that this is not an all inclusive description of all violative labeling for your OTC drug product.”

via healthkey.com

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Monday, April 18, 2011

FDA orders safety studies for some asthma drugs | Reuters

U.S. health regulators have ordered drugmakers to conduct clinical trials involving a total of 53,000 patients to test the safety of a controversial class of inhaled asthma drugs that are already on the market.

The trials are being required to demonstrate the safety of medicines known as long-acting beta-agonists (LABAs) when used in combination with inhaled steroids, another class of asthma drugs, the U.S. Food and Drug Administration said on Friday.
LABAs to be studied are AstraZeneca's Symbicort, GlaxoSmithKline's Advair Diskus, Merck & Co's Dulera, and Novartis AG's Foradil.

via reuters.com

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Saturday, April 2, 2011

Medical News: FDA Sets Rules for Vending Machine Calorie Info - in Public Health & Policy, Public Health from MedPage Today

Chain restaurants, vending machines, and convenience stores would all have to prominently display the calorie counts of their foods under two proposed rules released by the FDA Friday.

The Affordable Care Act (ACA) mandated that vending machines and food establishments with 20 or more locations -- which includes fast-food restaurants, bakeries, coffee shops, and certain grocery and convenience stores -- display the calorie counts of their food items. The new rules would implement that portion of the law.

Establishments whose primary purpose is not to sell food -- such as movie theaters and bowling alleys -- would not be subject to the law, meaning giant tubs of buttery popcorn and pizzas and nachos wouldn't have to carry a calorie-count label.

via medpagetoday.com

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Thursday, March 24, 2011

Popcorn, movies, nutrition, calories: Cinema chains fight federal nutrition disclosure rules on popcorn, other snacks - latimes.com

Theater owners to the FDA: Don't mess with our popcorn.
The nation's cinema operators are fuming about proposed federal rules that could require them to disclose the calories in their concession food — including popcorn, a highly profitable item for theater chains.
Regulators could issue final rules as early as Wednesday that would force movie theaters to post calorie counts for popcorn, pretzels, hot dogs and other prepared foods sold in their cinemas. Packaged foods such as candy already carry nutritional information.
A provision in the federal healthcare law stipulates that restaurant chains with at least 20 U.S. locations must provide the calorie content of menu items. Last summer, the Food and Drug Administration indicated that it intended to apply the provision not only to restaurants but also to grocery stores and concession stands, including those at theaters.
Alarmed at the prospect, representatives of the National Assn. of Theatre Owners have been lobbying the FDA and congressional staff members in recent weeks to exempt theaters from the nutritional labeling requirement.

via latimes.com

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Friday, March 11, 2011

FDA takes over Johnson & Johnson's Tylenol plants - Mar. 10, 2011

The government is taking over three Tylenol plants following a blizzard of drug recalls and a Food and Drug Administration criminal investigation into safety issues at the factories.
The FDA and the Justice Department on Thursday took action against McNeil PPC and two of its executives -- its vice president of quality and its vice president of operations for over-the-counter products -- for failing to comply with federally-mandated manufacturing practice.

McNeil, a division of Johnson & Johnson (JNJ, Fortune 500), said it had agreed to put its plants -- one in Las Piedras, Puerto Rico, one in Fort Washington, Pa. and one in Lancaster, Pa., under FDA supervision.

The agreement, known as a "consent decree," is subject to approval by a federal judge in Pennsylvania.

via money.cnn.com

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Wednesday, February 23, 2011

Drug maker cited for not reporting side effects - Health - Health care - msnbc.com

U.S. health regulators have warned Sanofi-Aventis SA's U.S. unit for failing to submit reports of possible serious side effects in a timely manner.

In a January 28 letter made public on Tuesday, the Food and Drug Administration said an early response from the drugmaker and its "promised corrective actions are inadequate to address the deficiencies."

"We remain concerned that your .... adverse drug experience reporting system has not been fully validated, and may have resulted in inaccurate assessment and untimely submission of 15-day alerts," FDA said.

via msnbc.msn.com

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Thursday, April 21, 2011

Hand sanitizers: don't kill MRSA or E. coli, says FDA - Health Key

Monday, April 18, 2011

FDA orders safety studies for some asthma drugs | Reuters

Saturday, April 2, 2011

Medical News: FDA Sets Rules for Vending Machine Calorie Info - in Public Health & Policy, Public Health from MedPage Today

Thursday, March 24, 2011

Popcorn, movies, nutrition, calories: Cinema chains fight federal nutrition disclosure rules on popcorn, other snacks - latimes.com

Friday, March 11, 2011

FDA takes over Johnson & Johnson's Tylenol plants - Mar. 10, 2011

Wednesday, February 23, 2011

Drug maker cited for not reporting side effects - Health - Health care - msnbc.com

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