Regulatory News

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.
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.
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.
e-cig solution
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."
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.
Teleflex Medical is in the process of recalling 9,333 units of its Hudson RCI manual ventilator for emergency resuscitation.
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.
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.
allergy sufferers
The recall is the result of failed impurities and a specification being reported for impurity at the 21-month stability time point.
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.
electronic cigarettes
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.
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.
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.
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.
Swiss drugmaker Novartis said European health regulators have approved its ALK inhibitor Zykadia (ceritinib) for advanced lung cancer.
The US FDA has approved the antibiotic moxifloxacin (Avelox) to treat septicemic and pneumonic plague.
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.
The FDA has released enhanced recommendations on the production and disinfection of reusable medical devices, according to a press release.
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.
The FDA has approved Anthrasil, Anthrax Immune Globulin Intravenous (Human), to treat patients with inhalational anthrax in combination with appropriate antibacterial drugs.