Regulatory News

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.
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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.
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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.
The joint lawsuit from the Academy of Allergy & Asthma in Primary Care (AAAPC) and United Allergy Services (UAS) aims to resolve allegations of anti-competitive practices among the AAAAI, ACAAI, and JCAAI, according to a news release by AAAPC.
Researchers have found the Surgeon General's report of 1964, which first outlined the dangers of smoking and led to the development of tobacco control efforts, is responsible for adding nearly 20 years of life to eight million Americans.
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A new study from the University of Michigan finds that 44 percent of adults worry that the devices will encourage kids to use tobacco products.
The new guidelines and updated disease definition are intended to help doctors confirm a diagnosis of severe asthma, and address associated factors that make it difficult to treat.
The vaccine, Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, is for use in people 18 years of age and older who are at increased risk of exposure to the H5N1 influenza virus.
Commentary by the organization's president and CEO notes the ongoing quality and safety problems in healthcare, despite substantial and concentrated efforts to resolve the problem.