Regulatory News

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Calls for e-cigarette regulation are growing louder as big tobacco companies move in to the market, which is forecasted to top $10 billion annually by 2017.
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The 21st Century Cures Act would require the FDA to streamline its drug approval process, consider more flexible forms of clinical trials, and incorporate patient experience into its decision-making process.
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Hawaii recently became the first state to prohibit the sale of tobacco products to youth under the age of 21. In most states the legal age is 18.
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Federal and state lawmakers have urged the FDA to accelerate its push to regulate e-cigarettes and have expressed alarm about nicotine poisonings related to "e-liquids."
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According to an association press release, the American Thoracic Society supports the US Supreme Court's June 25 ruling to back federal tax subsidies to aid American in purchasing health insurance.
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Teleflex Medical is in the process of recalling 9,333 units of its Hudson RCI manual ventilator for emergency resuscitation.
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In a 6-3 decision, the US Supreme Court backed President Obama’s healthcare law federal tax subsidies intended to help poor and middle-class people buy health insurance.
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Last week the House voted 280-140 to repeal the medical device tax, a 2.3% excise tax charged to the makers and importers of medical equipment.
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The recall is the result of failed impurities and a specification being reported for impurity at the 21-month stability time point.
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The CDC is investigating what appears to be an accidental shipment of live anthrax from the Defense Department to laboratories in nine states, according to a CDC statement.
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The FDA Center for Tobacco Products (CTP) will hold its third and final public workshop to obtain information on electronic cigarettes and the public health on June 1-2, 2015.
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The US FDA has approved Stiolto Respimat (tiotropium bromide and olodaterol) Inhalation Spray as a long-term, once-daily maintenance treatment of airflow obstruction in patients with COPD.
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The FDA has issued the first warning letters to e-cigarette companies for illegal claims on their websites, according to an article published in JAMA.
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Vertex's investigational drug Orkambi (lumacaftor/ivacaftor) could potentially treat 8,500 Americans with cystic fibrosis aged 12 and older with two copies of the F508del mutation.
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Swiss drugmaker Novartis said European health regulators have approved its ALK inhibitor Zykadia (ceritinib) for advanced lung cancer.
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The US FDA has approved the antibiotic moxifloxacin (Avelox) to treat septicemic and pneumonic plague.
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B&B Medical Technologies has received ISO 13485 Certification and Health Canada Medical Device Licenses to sell the B&B Bubbler and HOPE Nebulizer into the Canadian market.
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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.