Category Archives: FDA

Statistical Tinkering in Device Regulation a Disservice to Patients

Despite the regulatory approval of new antiepileptic drugs (AED) over the past decade and the expansion of indications deemed suitable for epilepsy surgery, individuals with intractable seizures – roughly one in three epilepsy patients – still face a dearth of…

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‘Fast’ Progress: Ampligen Activist Ends Hunger Strike

Robert Miller, the patient advocating for Hemispherx Biopharma Inc.’s Ampligen (rintatolimod) for chronic fatigue syndrome by going on a hunger strike in protest of the FDA’s complete response letter, ended the hunger strike over the weekend. Progress was made, he said,…

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On the ‘Gom-Boo,’ Ampligen, and Holding Out Hope

About a week ago, my obituary arrived by email. But something related, which you might think is weirder, happened Tuesday afternoon, and all of it involves chronic fatigue syndrome (CFS), and Hemispherx Biopharma Inc.’s drug candidate for it, Ampligen. More…

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Don’t Call Them Generics!

When the FDA’s Rachel Sherman said the biggest challenge the agency faces with biosimilars is educating the public, she wasn’t exaggerating. An article in the New York Times shows just how big of a challenge it’s going to be. The…

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FDA’s Confusing Action Against Burzynski – What Does it Really Mean?

Last month the FDA’s Office of Prescription Drug Promotion (OPDP) issued a warning letter to the Burzynski Research Institute Inc. and the Burzynski Clinic regarding claims made for its antineoplastons A10 and AS2-1 injections that violate the Federal Food, Drug,…

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Where’s Rube Goldberg When You Need Him?

What’s the difference between Congress and a Rube Goldberg contraption? They both use convoluted processes to accomplish a simple task, but the Goldberg invention still manages to keep the end result pretty simple. And while there may be some unintended…

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Caught in Its Own Snare

A hunter walks into a bar and says, “Did you hear the one about the FDA?” “You mean the time it shot itself in the foot?” the bartender responds. “The left foot or the right foot?” another hunter asks, wiping…

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It’s the Pounds, Stupid

At a family wedding earlier this month, an uncle was salivating over the prospect that the Vivus Inc. drug Qnexa could soon become the first in a new generation of obesity drugs to gain FDA approval. He needed to lose…

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Biotech Falls For April Fools’ Prank – Again!

The contenders for becoming the April Fool in Life Sciences for 2012 came down to three candidates, but two of them have persisted past the April 1 deadline, thereby removing themselves from consideration. President Barack Obama still has a glimmer…

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The Death of ‘Innocent Until Proven Guilty’?

Unlike every other country in the world at the time, the U.S. founded its judicial system on the premise “innocent until proven guilty.” Under that guiding principle, the burden of proof – in any enforcement action – lies with the…

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