Regulatory News

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The FDA has released enhanced recommendations on the production and disinfection of reusable medical devices, according to a press release.
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A Medscape news report indicates that the US House of Representatives voted overwhelmingly to repeal Medicare's sustainable growth rate (SGR) formula for physician reimbursement.
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The FDA has approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs.
FDA approves expanded use of Kalydeco for CF
The US FDA has expanded the approved use of Kalydeco for children aged two to five years with cystic fibrosis who have one of 10 mutations in their CFTR gene.
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3B Medical Inc has filed a legal action in the United States District Court for the Middle District of Florida alleging antitrust violations by ResMed, according to a 3B news release.
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The US Drug Enforcement Agency has issued a nationwide alert about the dangers of the narcotic fentanyl, which is often used in anesthesia to prevent pain after surgery or other procedures.
Thanks to a federal rule change, schools could start billing Medicaid for health services such as asthma screenings, vaccinations, and care for chronic diseases provided to some low-income students.
Actavis has launched its generic version of AstraZeneca’s Pulmicort Respules after a US District Court judge in New Jersey denied AstraZeneca’s request for a permanent injunction and invalidated its patent.
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New York Governor Andrew M. Cuomo’s administration will ban hydraulic fracturing (or "fracking") in New York State due to concerns over health risks, according to a Dec 17 report in the New York Times
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Drive Medical has successfully obtained ISO 13485:2003 certification, according to a news announcement from Harvey Diamond, board chairman and CEO of Drive Medical.
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The Hamilton-T1 transport ventilator is now approved in the EU with a neonatal option, according to the company.
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Arnuity Ellipta (fluticasone furoate inhalation powder) is a once-daily ICS for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older.
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A White House department reportedly edited language in the FDA's proposed rules for tobacco products that may weaken and limit the agency's ability to regulate e-cigarettes and cigars, according to published documents cited by a Reuters news article.
Halyard Health
Kimberly-Clark Corp has filed a Form 10 Registration Statement with the SEC to spin-off its Kimberly-Clark Health Care business and rebrand it Halyard Health Inc, which would be based in Alpharetta, Ga.
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Flight Medical Innovations Ltd has received FDA 510(k) clearance for its Flight 60 ventilator integrated O2 mixer version, and three advanced ventilation modes, according to a company announcement.
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The FDA has proposed a new rule that would extend the agency’s tobacco authority to regulate additional tobacco products, most notably electronic cigarettes (e-cigarettes), cigars, and other popular alternatives to cigarettes.
Spacelabs Healthcare is recalling the Arkon Anesthesia System with Version 2.0 Software due to a software defect that may cause serious adverse health consequences, including hypoxemia and death, according to an FDA announcement.
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Grastek, a sublingual allergen extract manufactured by Merck & Co Inc, has received FDA approval as an immunotherapy for the treatment of Timothy grass pollen-induced allergic rhinitis.
Aerocrine FeNO test
Health Care Service Corporation will begin covering FeNO testing for asthma diagnosis and management effective April 1, 2014, according to a press announcement by Aerocrine.
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Doribax (doripenem), an antibacterial drug that has been used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to similar antibacterial drugs, according to the FDA.