Food and Drug Administration
A picture taken on May 11, 2012 in a pharmacy in Paris shows a box of antiretroviral drug Truvada. The U.S. Food and Drug Administration (FDA) Antiviral Drugs Advisory Committee approved Gilead Sciences' Truvada as a preventative treatment for people who are at high risk of contracting HIV through sexual intercourse on May 10, 2012. Already approved to treat people infected with HIV, Truvada would be a milestone in the worldwide AIDS epidemic by offering a tablet capable of preventing infection in high-risk individuals.
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Quotes
The acceptance by FDA of this 4-factor PCC BLA marks an important step toward addressing the urgent unmet need for a rapid and simple way to reverse the effects of warfarin during bleeding emergencies
Approval of Absorica represents our third FDA approval and most important milestone to date, reflecting the great work by our Scientific Affairs team at Cipher and our partner, Galephar Pharmaceutical Research ... We look forward to working closely with our partner, Ranbaxy Laboratories Inc., in preparation for the upcoming U.S. launch of the product through its dermatology sales force.
The NDA filing with the FDA represents a significant achievement in the development of KYNAMRO™ and our efforts to get this important new drug to the market for patients who are at high-risk of a cardiovascular eventMore quotes »
Newsday's coverage
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FDA Warns of Fake Version of ADHD Drug Adderall
disorder drug Adderall, sold online, contains the wrong active ingredients, according to the U.S. Food and Drug Administration.Adderall is also used to treat narcolepsy. The drug, made by Teva Pharmaceutical Industries , is currently in short supply in the 9:31 AM Read more »
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U.S. Senate's surprise bipartisan drug-bill deal
defying the conventional wisdom that election year rancor has made it impossible to get anything done.The Food and Drug Administration Safety and Innovation Act could save both lives and money. Still it's remarkable that any bill, no matter how deserving, Read more »
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Editorial: Require alerts on drug shortages
Medical Association has called the situation a public health emergency.Under an executive order issued in November, the Food and Drug Administration asked drugmakers to voluntarily report production disruptions. The result has been a sixfold increase in notifications Read more »
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New Blood Thinner May Lower Chances of Clots in High-Risk Heart Patients: FDA
blood thinner Xarelto appears to lower the chances of potentially fatal blood clots in high-risk heart patients, a U.S. Food and Drug Administration review has found.The review came in briefing documents that were filed Monday in advance of an FDA advisory Read more »
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Gillibrand wants alerts on drug shortages
Senate to pass a bill, expected to come up for a vote this week, that would require drug manufacturers to alert the Federal Drug Administration of impending shortages six months beforehand."Parents should not have to worry and wait in line for lifesaving medicines Read more »
Around the web
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Health Buzz: Fake ADHD Drugs Hit Market
warning about fake versions of Adderall, a popular drug used to treat attention deficit hyperactivity disorder. The U.S. Food and Drug Administration said Tuesday that fake 30-milligram doses are being peddled online, and that they contain painkillers that 24 m ago from U.S. News & World Report Read more »
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FDA issues warning about fake Adderall
Wednesday morning for a man who went missing in the Great Miami River.Full Story > OKLAHOMA CITY (KOCO/CNN) - The Food and Drug Administration has a warning for people who buy Adderall online - the pills could fakes. Adderall is approved to treat attention 43 m ago from FOX 19 News Cincinnati Read more »
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Dave Murphy: 20 Years of GMO Policy That Keeps Americans in the Dark About Their Food
as the New York Times reported last week in a front-page story . More than a million people have asked the U.S. Food and Drug Administration (FDA) for mandatory labeling of genetically engineered food on a legal petition in March and on May 2, nearly a million 45 m ago from The Huffington Post Read more »
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EndyMed Medical Received FDA Clearance for its Glow by EndyMed™ Device...
use of multi-source radiofrequency for professional aesthetic treatments, announced today that the company has received USA Food and Drug Administration (FDA) clearance for its Glow by EndyMed™ device. The Glow by EndyMed was approved for dermatologic procedures 50 m ago from PRWeb Read more »
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Osiris shares up as FDA clears reimbursement pathway for wound treatment
technology company's wound treatment received a temporary reimbursement code from U.S. health regulators. The U.S. Food and Drug Administration assigned a temporary reimbursement code for Osiris's wound-care matrix containing stem cells on Tuesday. The regulator 57 m ago from Reuters Read more »
