Obama Care

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Get the targeted General Electric Healthcare email list for massive ROI
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Buy the targeted Get the targeted General Electric Healthcare email list from Pegasi Media Group to secure high ROI from our General Electric Healthcare email list.Please enter a description.... [...]
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Activate Microsoft Office 365 | Microsoft Office Setup | Office.Com/Myaccount
www.party.biz
Office.Com/Myaccount, Www.Office.Com/Myaccount - For all the MS Office setup users, we serve as the third party support provider for all the MS Office setup issues and troubleshooting all the concerning of office.com/setup. [...]
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Impeachable ?
forums.accuratereloading.com
Ummmm exactly...Supporting socialist obama take over of us healthcareMike [...]
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FDA Reconsiders Painkiller Training Requirements for Doctors
www.nbcnews.com
A panel of FDA advisers put in place nearly four years ago meets next week to review risk-management plans to reduce misuse and abuse of long-acting painkillers, powerful opioid drugs at the center of a national wave of abuse and death. Under the ... [...]
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FDA Again Reviews Mandatory Training for Painkiller Prescribers
www.nytimes.com
On Tuesday, a new F.D.A. panel of outside experts will meet to review once again whether such training should be required. The hearing will almost certainly touch off an intense debate inside the medical community and focus attention on medical groups ... [...]
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FDA Pumps Money Into Campaign to Counter Tobacco Use in LGBT Community
abcnews.go.com
“This is the biggest LGBT health initiative that's ever existed," said Doctor Scout, director of LGBT HealthLink, who was consulted by the FDA in making the ads. A lot of tobacco control has not focused on LGBT people, "despite our huge smoking rate ... [...]
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Recent FDA warning letters cite seafood, dairy, soybean firms
www.foodsafetynews.com
FDA's April 21 letter to Constantine Poulos and Company, dba International Foods, in Burlington, VT, noted that an inspection done on Feb. 1, 8 and 11, 2016, of the company's processing plant in Williston, VT, revealed problems during the manufacture ... [...]
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The Cost of Developing an FDA-Approved Drug Is Truly Staggering, Study Shows
www.fool.com
These post-approval costs are a condition of approval from the FDA. Thus, the grand total is more like $2.87 billion in direct and indirect costs per approved drug! Keep in mind, as well, that this study was conducted a few years prior, so it's quite ... [...]
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FDA approves first generic Crestor
www.fda.gov
“The FDA is working hard to get first-time generic drugs approved as quickly as possible so patients can have increased access to needed treatments,” said Kathleen Uhl, M.D., director of the Office of Generic Drugs in the FDA's Center for Drug ... [...]
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FDA approves first drug to treat hallucinations and delusions associated with …
www.fda.gov
“Hallucinations and delusions can be profoundly disturbing and disabling,” said Mitchell Mathis, M.D., director of the Division of Psychiatry Products in the FDA's Center for Drug Evaluation and Research. “Nuplazid represents an important treatment for ... [...]
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Dole Knew About Listeria Problem at Salad Plant, FDA Report Says
www.nytimes.com
A Dole vessel in Guayaquil, Ecuador. An F.D.A. report shows that products in a Dole salad plant tested positive for listeria nine times before F.D.A. inspectors showed up to do a test in January at a plant in Springfield, Ohio. Credit Guillermo Granja ... [...]
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First Commercial Zika Virus Test Gets FDA Approval
www.nbcnews.com
"Until now, the only Zika tests authorized by the FDA under EUA were available from the CDC and were only used in qualified laboratories designated by the CDC. Quest Diagnostics plans to make the new test broadly available to physicians for patient ... [...]
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There's a new sheriff in town in Silicon Valley — the FDA
www.washingtonpost.com
As a tidal wave of new health-related gadgets, apps and tests hits the market, government agencies like the FDA, Federal Trade Commission and others are showing up in Silicon Valley like they've never done before. They have slapped companies such as ... [...]
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Mental Dystrophy at the FDA
www.wsj.com
FDA's reviewers threw up a litany of concerns that also don't stand scrutiny: The drug doesn't produce dystrophin, or not enough, or who cares because there's no correlation between dystrophin levels and a boy's performance. But not even FDA purports ... [...]
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FDA Panel Finds Evidence Inadequate for Eteplirsen in DMD
www.medscape.com
Despite sometimes emotional testimonials from boys with Duchenne muscular dystrophy (DMD) and their families, the Food and Drug Administration's (FDA's) Peripheral and Central Nervous System Drugs advisory committee has determined that studies of ... [...]
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FDA Clears Bevespi Aerosphere for COPD
www.medscape.com
The US Food and Drug Administration (FDA) has approved the first long-acting muscarinic antagonist/long-acting beta-2 agonist combination in a pressurized metered-dose inhaler (pMDI), using novel co-suspension technology for chronic obstructive ... [...]
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Slim Sarepta Hopes Rest With Top FDA Official
www.barrons.com
An advisory panel convened Monday by the FDA recommended against approval after an emotional 11-hour meeting that featured strong support for the drug from DMD patients and doctors treating them. Woodcock, the director of the FDA's Center for Drug ... [...]
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Health|FDA Urges Caution on Yeast Infection Drug During Pregnancy
www.nytimes.com
The F.D.A. had previously warned that chronic high doses of the drug, fluconazole (brand name Diflucan), might be linked to “a rare and distinct set of birth defects” in infants whose mothers took it in the first trimester. Those doses ranged from 400 ... [...]
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Pharmalot, Pharmalittle: FDA panel reviewing Duchenne muscular dystrophy drug
www.statnews.com
Good morning, everyone, and welcome to another working week. We hope the weekend respite was refreshing and invigorating, because this is quickly shaping up to be another busy stretch. The agenda includes a regulatory meeting, a congressional ... [...]
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FDA and WHO warn about clinical trials run by an Indian company
www.statnews.com
A notice was posted on the FDA web site one day after the agency sent a letter to Semler Research Center, which is based in Bangalore, India, saying that inspections found “significant instances of misconduct and violations of federal regulations ... [...]
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Advisers to FDA Vote Against Duchenne Muscular Dystrophy Drug
www.nytimes.com
The advisory panel voted 7 to 3, with three abstentions, that the clinical data did not meet the F.D.A. requirements for well controlled studies necessary for approval. However, some of the panel members had trouble reconciling the often compelling ... [...]
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FDA Proposes Ban On Certain Electrical Stimulation Devices
www.medicaldaily.com
The Judge Rotenberg Educational Center in Canton, Massachusetts is the only facility currently manufacturing and using these devices in the United States, the FDA said, adding that between 45 and 50 individuals are exposed to it. State-of-the-art ... [...]
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Could Desperate Parents' Pleas Sway The FDA To Approve A Drug Even If Evidence …
www.forbes.com
You don't usually hear people compare Food and Drug Administration advisory committee meetings to a world-class sporting event, but this is how Brian Denger described the one set for Monday: “For the Duchenne community, this is going to be more like ... [...]
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An Investors' Guide to Sarepta's Eteplirsen FDA Advisory Panel Meeting
www.thestreet.com
I've been writing about the biotech industry and biotech investing for 15 years and I've covered U.S. Food and Drug Administration advisory committee meetings for just as long. One of the first FDA meetings I remember writing about involved Idec ... [...]
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FDA Nearing Decision on Drug Implant
www.painnewsnetwork.org
The latest results from a Phase 3 double blind study of a buprenorphine implant called Probuphine would appear to boost its chances of winning FDA approval. Titan Pharmaceuticals (NASDAQ: TTNP) said over 85% of the patients who had the implant for six ... [...]
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FDA proposes ban on electrical stimulation devices intended to treat self …
www.fda.gov
The FDA takes the act of banning a device only on rare occasions when it is necessary to protect public health. ESDs administer electrical shocks through electrodes attached to the skin of individuals to attempt to condition them to stop engaging in ... [...]
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House Dem: FDA guidelines will help shield medical devices from hackers
thehill.com
The FDA is moving to update its digital security recommendations as more medical devices are connected to the Internet. Security specialists increasingly worry that hackers could infiltrate hospital tools that control vital functions, such as pumps ... [...]
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The FDA vs. Austin Leclaire
www.wsj.com
No government agency controls the fate of more people than the Food and Drug Administration, which has the power to deny children a treatment that could help them walk. The FDA is reviewing an experimental drug for muscular dystrophy, and the outcome ... [...]
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FDA asks Noblesville pharmacy to pause manufacturing
www.indystar.com
A Noblesville compounding pharmacy company has ceased production and recalled its sterile products after a federal investigation of its facilities. Food and Drug Administration workers investigated the Pharmakon facility after the company issued a ... [...]
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FDA rejects TransEnterix's SurgiBot robot
www.newsobserver.com
The FDA's rejection of SurgiBot renders the ALF-X the company's most viable product. TransEnterix had already hired about two dozen sales and marketing employees to promote the ALF-X in Europe, where the device has been used in more than 200 ... [...]
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FDA Blocks Texas Import of Execution Drug
www.texastribune.org
The U.S. Food and Drug Administration has told the Texas Department of Criminal Justice it is tentatively barred from importing a drug used in executions, according to department spokesman Jason Clark. Clark said the FDA sent a letter to the department ... [...]
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As FDA prepares to regulate e-cigarettes, Congress pushes back
www.cleveland.com
If proposed FDA regulations take effect, he warned, he and others like him could wind up smoking more traditional -- and dangerous -- tobacco products again. A long-awaited set of government restrictions, testing requirements and health and safety ... [...]
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FDA launches first ad campaign focused on dangers of smokeless tobacco among …
www.fda.gov
“Not only is the target audience using smokeless tobacco at a high rate, but many do not fully understand the negative health consequences of their actions,” said Mitch Zeller, J.D., director of the FDA's Center for Tobacco Products. “In communities ... [...]
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CardioBrief: FDA Ends Niacin, Fibrate Combos With Statins
www.medpagetoday.com
The FDA is putting an end to the combined use of statins with two once-popular lipid drugs, niacin and fenofibric acid. On Monday, the FDA will announce in the Federal Register that it is withdrawing its approval for indications for co-administration ... [...]
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Chiasma shares plummet after FDA rejects drug
www.bostonglobe.com
FDA officials faulted the so-called single-arm design of Chiasma's clinical trial, which didn't compare patients taking its drug to others given a placebo, the company said. It said the agency recommended a placebo-controlled trial that would be more ... [...]
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UDI Compliance: What's Coming From FDA in 2016
www.raps.org
Class II medical devices will follow Class III and implanted devices later this year when they come into compliance with unique device identifier (UDI) regulations beginning in September, officials from the US Food and Drug Administration (FDA) told ... [...]
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Final FDA Guidance Focuses on Diagnostics Measuring Radiation Exposure
www.raps.org
The US Food and Drug Administration (FDA) has finalized guidance detailing the types of data and study considerations necessary to support the approval of diagnostics intended to measure levels of unintended radiation exposure in patients. Unlike ... [...]
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FDA Rescinds Approval of Carbadox to Treat Swine
foodpoisoningbulletin.com
The FDA is not recommending that anyone stop eating pork because of this finding. The potential cancer risks are based on an assume lifetime of consuming pork liver or other pork products containing residues of this drug. Short term changes in the diet ... [...]
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FDA Publishes Sixth FSMA Final Rule on Sanitary Transportation of Human and …
www.natlawreview.com
The U.S. Food and Drug Administration ("FDA") today officially published the sixth of seven total final rules implementing the Food Safety Modernization Act ("FSMA"). The final rule on Sanitary Transportation of Human and Animal Food establishes ... [...]
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FDA rejects Chiasma's Mycapssa NDA
seekingalpha.com
Chiasma (NASDAQ:CHMA) receives a Complete Response Letter (CRL) from the FDA regarding its New Drug Application seeking approval of lead product candidate and Orphan Drug-tagged Mycapssa (octreotide capsules) for the treatment of acromegaly, ... [...]
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Eve Of Prohibition: This Committee Could Stop The FDA Attack On E-Cigarettes
dailycaller.com
The House Committee on Appropriations could be the last line of defense against Food and Drug Administration (FDA) regulation that will wreck the e-cigarette industry. The FDA regulation, expected to be announced imminently, will require all e ... [...]
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Data Integrity in cGMP Drug Manufacturing: FDA Offers New Draft Guidance
www.raps.org
The recent influx of concerns over data manipulation and other data integrity questions in India, China and elsewhere has pushed the US Food and Drug Administration (FDA) to put out new draft guidance on Thursday to help the pharmaceutical industry ... [...]
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FDA approves folic acid fortification of corn masa flour
www.fda.gov
The U.S. Food and Drug Administration today approved folic acid fortification of corn masa flour. The approval allows manufacturers to voluntarily add up to 0.7 milligrams of folic acid per pound of corn masa flour, consistent with the levels of ... [...]
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FDA officials to visit tobacco farms
thehill.com
The Food and Drug Administration (FDA) plans to tour tobacco farms around the country this fall, even though they are not currently regulated by the agency. The FDA's Center for Tobacco Products is setting up the voluntary tours, which it insisted are ... [...]
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FDA Clears First Blood-Based Colorectal Cancer Screening Test
www.medscape.com
The first blood-based colorectal cancer (CRC) screening test, Epi proColon (Epigenomics AG), has been approved by the US Food and Drug Administration (FDA). It is already available in Europe and some other countries. The Epi proColon test is a ... [...]
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Chiasma's Acromegaly Drug Headed for FDA Rejection, Investor Says
www.thestreet.com
Chiasma (CHMA) is expecting the U.S. Food and Drug Administration to make an approval decision Friday on a new oral treatment for acromegaly, a rare disease of the pituitary gland. One of my most reliable (and bearish) investor sources believes the FDA ... [...]
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FDA Approves Adding Folic Acid to Masa Flour to Stop Birth Defects
www.nbcnews.com
"The approval allows manufacturers to voluntarily add up to 0.7 milligrams of folic acid per pound of corn masa flour, consistent with the levels of certain other enriched cereal grains," the FDA said in a statement. "Great news for babies!" the March ... [...]
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2015: An Important Year for Advancing Generic Drugs at FDA
blogs.fda.gov
At FDA's Office of Generic Drugs (OGD) in the Center for Drug Evaluation and Research, 2015 was an important year. It was our first full year of operation after vastly expanding our office's scope and structure. This change allowed for the office to ... [...]
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The FDA Is Putting The Squeeze On Pressed Juicery
laist.com
The FDA issued an initial warning after an October visit to the juice company's Fresno manufacturing facility, concerning the company's compliance with certain bacteria prevention measures. Pressed Juicery responded in November, but the agency found ... [...]
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FDA seeks comments on inorganic arsenic in infant rice cereal
www.foodsafetynews.com
A 90-day comment will provide the opportunity for the public and industry to suggest changes to the FDA's draft guidance for in organic arsenic in rice cereals for infants and toddlers. Details on how to comment and the draft guidance, as well as ... [...]
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Ecstasy could be sold as an FDA-approved drug within 5 years
www.sciencealert.com
Though small and preliminary, the results were encouraging enough to help lead to Phase 2 clinical trials – the second in the three sets of human trials required before the Food and Drug Administration (FDA) will consider a new drug for approval. In ... [...]
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Diverse mix of food manufacturers get FDA warning letters
www.foodsafetynews.com
The FDA warning letter informed MGH that its crab cakes, smoked salmon, lobster, shrimp, salon, smoked trout and ahi tuna canapés products are all considered to be adulterate because without following the seafood HACCP regulations, the fish and fishery ... [...]
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FDA Clears Use of Experimental Test for Screening Blood for Zika
www.nytimes.com
A blood donation center in Lafayette, La. The F.D.A. approved an experimental test to screen blood donations for Zika on Wednesday. Credit David Rae Morris for The New York Times. The Food and Drug Administration announced Wednesday that it would ... [...]
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FDA: 'Stop using' OxySure Model 615
www.wfaa.com
“OxySure strongly disagrees with both the content and import of the FDA's March 29, 2016, safety notice about the OxySure Model 615 device. We are sure that the thousands of people saved over the years with our product also disagree. Notably, the ... [...]
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FDA expands abortion-pill access in states seeking limits
www.usatoday.com
The new guidelines strike directly against laws passed by several states — including North Dakota, Ohio and Texas — that require doctors to adhere to 16-year-old FDA regulations. Several other states have tried to limit use of the drug, but their ... [...]
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Report: FDA's Drug Approval Process Shows Slight Improvement
www.newsweek.com
That's why there's pressure on the U.S. Food and Drug Administration (FDA) to quickly approve therapies that are effective in clinical trials. A new report highlights the challenges of this approval process. According to the California Life Sciences ... [...]
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How FDA aims to support generic opioids
formularyjournal.modernmedicine.com
FDA issued a draft guidance to support industry in their development of generic versions of approved opioids with abuse-deterrent formulations (ADF), while ensuring that generic ADF opioids are no less abuse-deterrent than the brand-name drug. This is ... [...]
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FDA proposes ban on most powdered medical gloves
www.fda.gov
“This ban is about protecting patients and health care professionals from a danger they might not even be aware of,” said Jeffrey Shuren, M.D., director of FDA's Center for Devices and Radiological Health. “We take bans very seriously and only take ... [...]
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