Regulatory News

White House
The American Lung Association (ALA) has given the Obama administration an "incomplete" grade for not promptly granting the FDA regulatory authority over non-cigarette tobacco products.
The FDA has issued a draft guidance that outlines important steps for medical device manufacturers to monitor, identify, and address post-market cybersecurity risks.
The FDA approved 45 drugs with never-before-sold ingredients in 2015, edging past 2014's tally of 41, which had been the highest number since 1996.
An FDA director responded to criticism over the agency's approval process of the nasal spray naloxone (Narcan), an opioid overdose reversal agent intended to be administered by EMS personnel.
RT has published an exclusive tablet-only “Best of 2015” edition for December that takes a look back at some of the year’s most important respiratory, critical care, and emergency medicine news and research.
The FDA has cleared Luminex Corp's NxTAG Respiratory Pathogen Panel, which detects 20 clinically relevant viral and bacterial respiratory pathogens.
Uptravi (selexipag, Actelion Pharma) is an oral IP prostacyclin receptor agonist that relaxes muscles in the walls of blood vessels in order to dilate them and decrease elevated blood pressure.
China cigarette smoking
A Singapore-based court has refused a challenge by Philip Morris to Australia's landmark plain packaging legislation passed in 2011.
The FDA has approved a new indication for Zoll Corp's LifeVest wearable cardioverter defibrillator, which can now be prescribed for certain pediatric patients at risk of sudden cardiac arrest.
cigarette plain package
Several tobacco companies are suing the British government arguing that the UK's plain packaging law unlawfully takes away its intellectual property, according to Medpage Today.
ventilated patient
The FDA has approved Bridion (sugammadex) injection to reverse the effects of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide, which are used to facilitate intubation procedures and mechanical ventilation.
Alectinib (Alecensa, Genetech) is an oral medication that blocks the activity of the ALK protein, which may prevent NSCLC cells from growing and spreading.
Reslizumab has been recommended for approval by an FDA advisory committee for use in treating adults 18 years and older with asthma.
Hospitals that fell into the lowest quartile of CMS's hospital-acquired conditions (HAC) reduction program this year will forgo about $364 million in payments during FY 2016.
RSV vaccine
The new vaccine is trivalent, produced from three influenza strains: two subtype A and the other type B. It is indicated specifically for people aged 65 years and older.
The Food and Drug Administration has approved Tagrisso (AZD9291) for the treatment of a specific type of non-small cell lung cancer.
The FDA is adding a new indication to anthrax vaccine BioThrax, first approved in 1970, to prevent anthrax after suspected or confirmed exposure to Bacillus anthracis in individuals age 18 to 65.
Dabigatran (Pradaxa) has received FDA approval for prevention of deep vein thrombosis and pulmonary embolism in patients undergoing hip replacement surgery.
The FDA determined there is a low likelihood the products will lead to increased tobacco use in the population, prevent people from quitting, or cause those who have quit to relapse.
The FDA has cleared Mallinckrodt Pharma's INOmax DSIR Plus MRI device for delivery of INOmax (nitric oxide) for inhalation during MRI procedures.