Is Sponsor-Submitted Clinical Data Safe? The U.S. Food and Drug Administration has a tricky task at hand when it comes to reviewing, evaluating, investigating and eventually approving prescription medications. Yes, the agency has a mission to ensure patient safety, and yes, a formal process must be followed before a medication […]

The road to U.S. Food and Drug Administration approval of pharmaceutical manufacturers’ medications is a long and winding one. A dynamic process tinged with favorable – and unfavorable – factors can take a drug from lab to label in 10 months or less. Consumer clarity on how certain products make […]

An all too familiar campaign of denial. It seems like every week a different retired football player from the National Football League publically reveals their private struggles with post-football related health issues, and particularly those attributable to Chronic Traumatic Encephalopathy, or CTE.  CTE is a progressive degenerative disease found in […]

Cyber attacks have broken free from their initial molds of carting off with consumer credit card numbers or stealing someone’s identity. The act of digitally digging into cyberspace has hit the U.S. Department of Health & Human Services and some of its 11 government agencies. Instead of hackers hounding out […]

The nominee for the top job at the U.S. Food and Drug Administration is being held hostage by Congress until the agency agrees to revamp its approval process for opioid painkillers. Sen. Ed Markey, D-Mass., has led the delay in appointing Robert Califf to the position of commissioner until the […]

One of the foremost father figures in the history of medicine famously said, “There are in fact two things, science and opinion; the former begets knowledge, the latter ignorance.” Hippocrates, the ancient Greek physician revered for high ethical and moral standards that are the reason every doctor in America pledges […]

Gone are the days when smoking cigarettes was universally viewed as a sign of strength, sexiness or sophistication. The tobacco industry’s effective—and deceitful—advertising campaign rolled out over the last century finally came under fire as more and more studies revealed the dangers and addictiveness of smoking . Instead of being […]

Florida lawyers are once again at the forefront of litigation against Big Tobacco, as last week a class action lawsuit against the maker of American Spirit cigarettes, and its parent company, was filed in Federal Court in Miami. American Spirit cigarettes are made by Santa Fe Natural Tobacco Company (SFNTC), […]

I have never been to Hawaii.  But as I understand it, “aloha” is used to say hello and goodbye.  And starting soon, aloha will mean goodbye to cigarettes if you are under the age of 21, as last week Hawaii became the first state in the nation to ban smoking […]

Last Friday, Hawaii’s state legislature passed a bill to prohibit the sale of cigarettes and other tobacco products to individuals under the age of 21.  Should Governor Ige sign the measure, it would become law on January 1, 2016, making Hawaii the strictest state concerning such sales.  New Jersey, Alabama, […]