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FDA and industry reach agreement in principle on medical device user fees
The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. The recommendations would authorize the FDA to collect $595 million in user fees over five years, plus adjustments for inflation. Details of the agreement, such as the fee structure, are expected to be finalized soon.
FDA approves Gleevec for expanded use in patients with rare gastrointestinal cancer
The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.
FDA approves Kalydeco to treat rare form of cystic fibrosis
The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator (CFTR) gene.
FDA takes action against New York cheese manufacturer
The U.S. Food and Drug Administration is asking a federal court to prevent a New York cheese manufacturer from operating because of a history of unsanitary conditions and producing cheese in a facility contaminated with Listeria monocytogenes bacteria.
FDA approves new treatment for most common type of skin cancer
Today, Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal cell cancer who are not candidates for surgery or radiation and for patients whose cancer has spread to other parts of the body (metastatic).
FDA approves Inlyta to treat patients with a type of advanced kidney cancer
The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.
Department of Justice files Consent Decree of Permanent injunction against Ranbaxy
Generic drug manufacturer agrees to remedy deviations from the current good manufacturing practice requirements and to correct data integrity problems at numerous facilities
Maine company holds cold smoked salmon product after FDA order
A Maine food processing and storage company destroyed its cold smoked salmon product under the supervision of the U.S. Food and Drug Administration after inspectors found Listeria monocytogenes within the firm’s facility and on processing equipment
FDA permits marketing of first test for risk of rare brain infection in some people treated with Tysabri
Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn’s disease (CD).
FDA approves Voraxaze to treat patients with toxic methotrexate levels
The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure.
Methotrexate is a commonly used cancer chemotherapy drug normally eliminated from the body by the kidneys. However, patients receiving high doses of methotrexate may develop kidney failure.
FDA completes work on three drug user fee programs
The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients, FDA Commissioner Margaret A. Hamburg, M.D. said today. The recommendations were transmitted to Congress today by Health and Human Services Secretary Kathleen Sebelius.
FDA expands use of endovascular graft to treat aortic tears
The U.S. Food and Drug Administration today expanded the approved usage for an endovascular graft manufactured by W.L. Gore and Associates Inc. to include treatment of life-threatening tears or ruptures of the aorta (thoracic aortic transection). (MB)
FDA to protect important class of antimicrobial drugs for treating human illness
The U.S. Food and Drug Administration today issued an order that prohibits certain uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys effective April 5, 2012.
FDA expands use of Prevnar 13 vaccine for people ages 50 and older
Prevnar 13, a pneumococcal 13-valent conjugate vaccine, was approved today by the U.S. Food and Drug Administration for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae.
FDA to approve shared system REMS for TIRF products
The U.S. Food and Drug Administration today approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products.
FDA: Chicago-area sandwich manufacturer agrees to stop production
The U.S. Food and Drug Administration announced today that a Chicago-area company has agreed to stop making its ready-to-eat sandwiches and produce after FDA investigators repeatedly found unsanitary conditions and bacterial contamination in the facility.
FDA expands use of HIV drug Isentress to children and adolescents
Isentress (raltegravir) was approved today by the U.S. Food and Drug Administration for use with other antiretroviral drugs for the treatment of HIV-1 infection for children and adolescents ages 2-18.
FDA: Do not use ShoulderFlex Massager
The U.S. Food and Drug Administration is warning consumers again not to use the ShoulderFlex Massager, imported by King International and sold by various companies, due to serious potential health risks.
FDA collaboration to monitor rare eye condition associated with cataract surgery
The U.S. Food and Drug Administration and other government and professional organizations today unveiled a program to monitor medical devices used in cataract surgery in an effort to stem outbreaks of a rare, inflammatory condition associated with the procedure.
FDA approves mechanical cardiac assist device for children with heart failure
The U.S. Food and Drug Administration today approved a medical device that supports the weakened heart of children with heart failure to help keep them alive until a donor for a heart transplant can be found.
The mechanical pulsatile cardiac assist device is called the EXCOR Pediatric System, made by a German company, Berlin Heart. The device comes in graduated sizes to fit children from newborns to teens.
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Little Blows to Head Add Up to Big Risk
Small hits to the head may add up to injuries for high school football players, according to a new study by the Purdue Neurotrauma Group at Purdue University in West Lafayette, Ind.
Purple Potatoes Lower Blood Pressure in Overweight People
When overweight people included two servings of purple potatoes a day in their diet for a month, they not only reduced their blood pressure, but they also didn't gain weight in the process, a small study shows.
Can Too Much Texting Make Teens Shallow?
Teens and young adults who text frequently -- such as more than 300 text messages a day -- may be risking more than sore thumbs, according to a new study.
Breastfeeding OK for Moms With Asthma
New moms with asthma can safely breastfeed without worrying that the practice will increase their child’s asthma risk, a new study shows.
Blood Test May Help Diagnose Depression
Researchers say they have developed a new blood test that may reliably detect depression.
Senior Moment or Something Worse? Yes/No Test May Tell
When are “senior moments” just a normal part of healthy aging, and when are they a sign of something more serious such as Alzheimer’s disease? This is the million dollar question, and the Alzheimer’s Questionnaire, a set of 21 yes or no questions that can be answered by a loved one or caregiver, may help answer it.
People Pleasers May Overeat at Parties
People pleasers may want to steer clear of this weekend’s Super Bowl parties in order to avoid a dietary fumble.
Sex and the Elderly: STD Risk Often Ignored
The rate of sexually transmitted diseases (STDs) has more than doubled among middle-aged adults and the elderly over the last decade, but the reasons for this are unclear.
Eating Behavior May Be Shaped by Who You Eat With
How you eat may depend on who you’re eating with, according to a study published in the online journal PLoS ONE.
New Heart Failure Risks: Fractures and Memory Problems
Two new studies shine a light on some lesser known consequences of heart failure: fractures and memory problems.
1 in 2 Stroke Survivors Has High Blood Pressure
A disturbing 47% of people who have had a stroke have poorly controlled high blood pressure, researchers say.
Itch Intensity and Scratching Pleasure Vary at Different Body Sites
Did you know that scratching one part of the body is more pleasurable than scratching another?
Norovirus Causes Most Hospital Infection Outbreaks
Norovirus is the leading cause of infection outbreaks in hospitals throughout the country, a new study reveals.
Sunny Skies Linked to Lower Stroke Risk
People who live in sunny places may have a lower risk of stroke, new research suggests.
In Dollars Alone, Cost of U.S. Child Abuse High
Each year in the U.S., there are no fewer than 579,000 new cases of child abuse -- and as many as 2.2 million. The annual cost, $124-$585 billion, is higher than that of diabetes or stroke.
New Drug Treats Fibroids With Fewer Side Effects
The drug ulipristal acetate effectively controlled bleeding and shrunk uterine fibroids in two new studies.
Signs of Alzheimer’s May Show Up Years Before Symptoms
Amyloid protein plaques in the brain are a hallmark of Alzheimer's disease. Now, new research shows that this plaque actually builds up gradually and causes subtle changes in memory and mental status even in some adults who are healthy.
Sleep Apnea Linked to Silent Strokes
A common sleep disorder is associated with an increased risk of symptomless, but serious, strokes called “silent strokes,” German researchers report.
Massage May Help Sore Muscles Recover
There may be more to love about massage than just the ahhhhh. A new study shows that kneading muscles after hard exercise decreases inflammation and helps your muscles recover.
Americans Sweet on Sugar: Time to Regulate?
Americans are eating unhealthy amounts of sugar, say researchers from the University of California, San Francisco, and excess sugar should be regulated like alcohol and tobacco, they contend.
1 Million Birth Control Pill Packs Recalled
Pfizer has recalled 1 million packs of Lo/Ovral 28 and generic norgestrel/ethinyl estradiol birth control pills. The pills, which must be taken in the correct sequence, are mixed up. Women using the products risk pregnancy.
Study: Stents as Good as Surgery at Keeping Neck Arteries Open
A less invasive approach for clearing neck arteries of dangerous plaque works just as well as surgical treatment for most people at high risk of stroke, according to the largest comparison of the two procedures to date.
New Type of Prostate Cancer Pill Extends Lives
An experimental pill that works differently than other prostate cancer drugs extended the lives of men with spreading cancer by an average of nearly five months.
Heartburn Drugs Linked to Hip Fractures in Women
Postmenopausal women with a history of smoking who take heartburn drugs called proton pump inhibitors (PPI) for two years or longer may be more likely to sustain a hip fracture.
Study: Radioactive Seeds Beat Out Other Prostate Cancer Treatments
For most men with prostate cancer, having radioactive seeds implanted in the prostate is associated with fewer serious side effects than either surgery to remove the prostate or having a beam of high-energy radiation aimed directly at the cancer, researchers say.
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