FDA Tag Page
Singulair
It is being reported in the News that the FDA is investigating Singulair and the reports of mood changes, suicidal behavior in people taking Singulair.
Why did this get my attention?
Well, if you have listened to any of the drug commercials these days. It is absolutely ridiculous. Most of them sound like the side effects are worse than the condition you are taking them for. A couple even mention the risk of cancer.
Now, why would you take Singulair, which is an asthma medication, if the side effects sounded worse than the asthma?
I realize some medicines have side effects that are bad, [...]
F.D.A. sets up Beijing Office - Can it guarantee safety?
"We're opening up a new era, not just new offices." That's how Michael O. Leavitt of Health and Human Services described the F.D.A.'s presence in Beijing to screen at the point of manufacture food and drugs to be exported to the U.S. As Andrew Jacobs reports in THE NEW YORK TIMES, yesterday, the F.D.A. set up a permanent facility in China to ensure compliance with specifications. Leavitt also made the point that it was "clear you cannot inspect everything." Time will tell if the F.D.A. can
F.D.A. sets up Beijing Office - Can it guarantee safety?
"We're opening up a new era, not just new offices." That's how Michael O. Leavitt of Health and Human Services described the F.D.A.'s presence in Beijung to screen at the point of manufacture food and drugs to be exported to the U.S. As Andrew Jacobs reports in THE NEW YORK TIMES, yesterday, the F.D.A. set up a permanent facility in China to ensure compliance with specifications. Leavitt also made the point that it was "clear you cannot inspect everything." Time will tell if the F.D.A. can
Panel Questions Antipsychotics for Kids
Reuters is reporting that a panel of external experts is urging the U.S. Food and Drug Administration (FDA) and “other U.S. health agencies” to look at “the long-term effects” of antipsychotic drugs on children. The group met to review the safety of Risperdal—known generically as risperidone, and manufactured by Johnson & Johnson—and Zyprexa—manufactured by Eli Lilly [...]
AG goes after mobile home park
AG goes after mobile home park November 20, 2008 · Leave a Comment MESA — Operators for a mobile home park broke housing and civil rights laws when they booted an old couple without taking the wife’s mental disorder into consideration, according to a recent lawsuit. The complaint from the Arizona Attorney General’s Office claims Mesa Village Mobile Home Park near Main Street and Lindsey Road and two of its previous tenants, Herb and... [Read the full story] Growth State highway projec
Personal Injury Roundup No. 16 (11/21/08)
One scheduling note: there will be no Roundup next Friday; happy Thanksgiving! Reform, Legislation, Policy Massachusetts doctors say they're practicing defensive medicine out of fear of lawsuits [MassLive.com] Allegations of misconduct against FDA scientists [NYT] New Lawsuits Wrestlers sue college...
Psychotic Reaction: Treating ADHD In Maine
– Earlier this week, the FDA advisory committee slammed the rising use of antipsychotics in youngsters, particularly to treat attention deficit disorders. The meds, you see, were approved by the agency for schiozphrenia or bipolar disorder - and only recently for youngsters, in some cases (back story). The trend, however, to prescribe these meds for teenagers and children has actually been widespread, with Medicaid programs in several states reporting rising expenditures for antipsychotics
FDA Advisory Panel Rejects another NDA for a New Antibiotic
FDA Advisory Panel Rejects another NDA for a New Antibiotic A Food and Drug Administration (FDA) advisory panel Thursday rejected a proposed antibiotic by Arpida Ltd. (ARPN.EB) to treat serious skin infections, a Food and Drug Administration spokeswoman said. The rejection was expected because results from Phase III clinical trials showed that patients taking iclaprim (a trimethoprim-like antibiotic) had lower cure rates than Pfizer's Zyvox (linezolid) which was used as a comparator antibioti
Drugs' heart risk is FDA's biggest worry: official | Science & Health | Reuters
Drugs' heart risk is FDA's biggest worry: official | Science & Health | Reuters.
The steady erosion of freedom
Permalink Comments (0) Trackbacks (0) November 19, 2008 Blunt racism Prince George’s County, MD has approved a measure banning the sale of individual cigars. Stores must instead sell them in packs of at least five. But there are exceptions: Tobacco stores that specialize in cigar sales, and often sell high-end cigars for as much as $5 apiece or more, are excluded from the legislation’s restrictions, as are other locations that are sometimes age-restricted, including golf courses, fr
Palm Beach injury lawyer Susan Ramsey warns higher food poisoning with holidays
West Palm Beach food injury lawyer, Susan Ramsey, top in South Florida personal injury-food poisoning creates illness leading to wrongful death during holidays November 20, 2008, West Palm Beach, FL (JusticeNewsFlash.com)-Informed Palm Beach County Salmonella news and food poisoning attorney, Ramsey, is informing consumers more than 200,000 Americans get sick every day from what they eat. With Thanksgiving a week away and the remaining holiday bonanza around the consumer food consumption incre
Cuts, bonuses, and recession
I got an e-mail the other day from Rick Gould, managing partner at consulting firm StevensGouldPincus with a few pieces of advice for firm leaders who are trying to make their way through this devastating economy. The words in the headline showed up most in the e-mail he sent, as in: Cut wherever possible. No more temps, non-essential travel and entertainment, or freelancers. Layoffs may even be necessary. (Gould also recommends a hiring freeze.) And management should cut take pay cuts. Give
The Next Food Safety Czar will need to Work in Collaboration with Industry on Food Safety
The Next Food Safety Czar will need to Work in Collaboration with Industry on Food Safety I had a great meeting yesterday with ConAgra Foods. I met with a number of food safety employees and ConAgra’s Food Safety Board last time I visited Omaha a few months ago. According to its website and from what I can see, “ConAgra Foods has developed rigorous food-safety practices in all our facilities and manufacturing processes.” It goes on: One example is our foodborne pathogen control program. Thro
Protherics PLC Voraxaze Rolling BLA Submission Initiated with the US FDA
Protherics PLC Voraxaze Rolling BLA Submission Initiated with the US FDA - November 20, 2008 Trabectedin Company: Ortho Biotech Products, L.P. Treatment for: Ovarian Cancer Trabectedin is an investigational cytotoxic antitumor agent used in combination with Doxil (doxorubicin HCl liposome injection) for the treatment of women with relapsed ovarian cancer.Ortho Biotech Announces NDA Submission for Trabectedin for the Treatment of Relapsed Ovarian Cancer - November 20, 2008 Telavancin Injection C
Intel Announces its First Home Medical Device to Better Connect Clinicians With Patients
Intel(R) Health Guide is the First Product in a Series Designed to Enable More Personalised Care Management for Chronic and Age-related Conditions Intel Corporation today announced the Intel(R) Health Guide, a care management tool designed for healthcare professionals who treat patients with chronic conditions, for the UK. The Intel Health Guide represents Intel’s entry into a new category of personal health systems that go beyond the simple remote patient monitoring systems available today
Economist Argues That 7 Years Ought to be Enough for Biologic Data Exclusivity
As Congress is considering possible legislation to create an abbreviated pathway for the FDA to approve generic biologic therapies (“biogeneric,” “biosimilar” and “follow-on biologics”), differences in the R&D expense and product cost, and the potential for both new therapies post-approval and second-generation innovations have raised questions about how to achieve the proper balance between innovation and competition. One important policy for Congress to establish will be the number of ye
FDA Opens China Office
The U.S. Food and Drug Administration has been under fire for some time now over lapses in food and product safety, especially in its oversight of imports to the U.S. As this trend continues, the FDA has been discussing opening offices in key international locations. Now, USA Today is reporting that the FDA has opened [...]
Multiple Sclerosis: The Questions You Have, the Answers You Need
Multiple Sclerosis: The Questions You Have, the Answers You Need 640 pages | Demos Medical Publishing; 4th edition (October 28, 2007) | ISBN: 193260345X | PDF | 4 Mb This book, developed under the auspices of the Consortium of Multiple Sclerosis Centers and made possible by an educational grant to the consortium by Bertex Laboratories, the manufacturer of Betaseron, the first drug approved by the FDA for treatment of multiple sclerosis, represents an interdisciplinary approach to the disease
Waxman to run House Energy and Commerce Committee
The House Energy and Commerce Committee is one of the most powerful committees in the House of Representatives. It's especially important as we look at climate change legislation and fuel economy (both of which current chairman, John Dingell, has delayed and watered down). Newly selected Chairman Henry Waxman will be much more aggressive in pursuing good legislation on those fronts, but that's not the only reason to be excited about his ascendancy. Waxman made his name as an investigator, runn
US panel warns of Chinese espionage
China has stepped up computer espionage attacks on the U.S. government, defense contractors and American businesses, a congressional advisory panel said Thursday. The U.S.-China Economic and Security Review Commission also said in its annual report to lawmakers that aggressive Chinese space programs are allowing Beijing to target U.S. military forces better. "China is stealing vast amounts of sensitive information from U.S. computer networks," said Larry Wortzel, chairman of the commission set
Antibiotics and why you shouldn't buy them from Mexico...
My husband's parents are migrating old people. Every fall, somewhere around November, they drive to Texas for the winter. They stay until somewhere around April. At least a few times each month, if not each week, they cross the border into Mexico to Buy Stuff. They go to a warehouse full of clothing (Ropa Americana, "American clothes") like a gigantic Goodwill, only clothing is in huge piles to climb through rather than racks, and you pay for your items by the pound instead of by the piece. (The
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